Chrysalis Intelligence · Sponsors · Philips Ultrasound, LLC

Philips Ultrasound, LLC

Bothell, WA, US · 38 510(k) clearances · 116 recalls

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Total clearances
38
2020-03-06 → 2026-08-04
Last 12 months
9
Product codes
4
Most recent
2026-08-04
Name variants in FDA filings: Philips Ultrasound, LLC / Philips Ultrasound, Inc. / Philips Ultrasound
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 32 2026-08-04
LLZ System, Image Processing, Radiological Class II Radiology 3 2021-09-24
JAK System, X-Ray, Tomography, Computed Class II Radiology 2 2023-01-18
QIH Automated Radiological Image Processing Software Class II Radiology 1 2025-02-10
Safety

Recalls (116)

Class I (serious)
0
Risk of injury / death
Total recalls
116
Currently ongoing
103
Most recent
2025-10-31
DateSeverityStatusRecall # ProductCodeReason
2025-10-31 Class II Ongoing Z-0883-2026 Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, — Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
2025-09-05 Class III Ongoing Z-1628-2026 Philips X7-2 Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1627-2026 Philips X3-1 Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1626-2026 Philips S5-2 Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1625-2026 Philips S4-1 Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1624-2026 Philips OMNI III TEE Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1623-2026 Philips OMNI II TEE Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1622-2026 Philips Mini Multi TEE Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1621-2026 Philips L17-5 Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1620-2026 Philips L12-5 Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1619-2026 Philips C9-4 Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05 Class III Ongoing Z-1618-2026 Philips 3D6-2 Ultrasound Transducer — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2414-2025 XL14-3 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2413-2025 X8-2t Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2412-2025 X7-2t Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2411-2025 X7-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2410-2025 X6-1 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2409-2025 X5-1c Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2408-2025 X5-1 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2407-2025 X3-1 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2406-2025 X11-4t Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2405-2025 VL13-5 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2404-2025 V9-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2403-2025 V6-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2402-2025 TRANSDUCER L12-5 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2401-2025 Transducer C10-3v Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2400-2025 SCNHD LA L7-4 HDI Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2399-2025 S9-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2398-2025 S8-3t Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2397-2025 S8-3 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2396-2025 S7-2t Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2395-2025 S7-3t Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2394-2025 S5-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2393-2025 S4-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2392-2025 S4-1 Lumify Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2391-2025 S4-1 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2390-2025 S3-1 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2389-2025 S12-4 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2388-2025 OMNI III TEE Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2387-2025 OMNI II TEE Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2386-2025 mL26-8 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2385-2025 Mini Multi TEE Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2384-2025 mC7-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2383-2025 mC12-3 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2382-2025 L9-3 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2381-2025 L8-4 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2380-2025 L18-5 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2379-2025 L17-5 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2378-2025 L15-7IO TRANSDUCER Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2377-2025 L15-7io Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2376-2025 L12-5 50 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2375-2025 L12-5 38mm Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2374-2025 L12-4 Lumify Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2373-2025 L12-4 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2372-2025 L12-3 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2371-2025 L11-3 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2370-2025 L10-4LAP Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2369-2025 eL18-4 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2368-2025 D5cwc Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2367-2025 D2TCD Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2366-2025 D2cwc Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2365-2025 C9-5ec Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2364-2025 C9-4v Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2363-2025 C9-4 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2362-2025 C9-3v Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2361-2025 C9-3io Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2360-2025 C9-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2359-2025 C8-5 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2358-2025 C8-4v Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2357-2025 C8-4v Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2356-2025 C6-3 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2355-2025 C6-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2354-2025 C5-2 Lumify Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2353-2025 C5-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2352-2025 c5-1 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2351-2025 C10-4ec Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2350-2025 C10-3v Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2349-2025 BP10-5ec Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2348-2025 7.5MHZ Endo Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2347-2025 3D9-3v Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03 Class III Ongoing Z-2346-2025 3D6-2 Transducer Probe — To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-05-28 Class II Ongoing Z-2068-2025 Philips XL14-3 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2067-2025 Philips X8-2t Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2066-2025 Philips X7-2t Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2065-2025 Philips X6-1 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2064-2025 Philips X5-1 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2063-2025 Philips VL13-5 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2062-2025 Philips V6-2 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2061-2025 Philips S8-3t Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2060-2025 Philips S7-3t Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2059-2025 Philips S7-2 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2058-2025 Philips S5-1 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2057-2025 Philips L9-3 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2056-2025 Philips L8-4 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2055-2025 Philips L12-4 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2054-2025 Philips L12-3 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2053-2025 Philips eL18-4 EMT Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2052-2025 Philips eL18-4 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2051-2025 Philips C9-5EC Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2050-2025 Philips C5-2 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2049-2025 Philips C5-1 Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2025-05-28 Class II Ongoing Z-2048-2025 Philips 3D9-3v Transducer. — Ultrasound transducer devices were refurbished beyond their useful life.
2024-03-23 Class II Ongoing Z-1757-2024 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Pr… — Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selecte…
2023-10-09 Class II Completed Z-0284-2024 Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 — Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
2023-10-09 Class II Completed Z-0283-2024 Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 7… — Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
2023-06-30 Class II Completed Z-2517-2023 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2… — Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk…
2022-07-14 Class II Completed Z-1007-2026 Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201… — Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
2021-09-21 Class II Terminated Z-0123-2022 EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 — Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lea…
2021-08-19 Class II Terminated Z-0071-2022 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only, — Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternatin…
2021-08-19 Class II Terminated Z-0070-2022 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only, — Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternatin…
2021-08-06 Class II Completed Z-2484-2021 Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affini… — Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
2021-08-06 Class II Completed Z-2483-2021 EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795… — Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
2021-07-22 Class II Completed Z-2306-2021 EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi — Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the mon…
2020-12-24 Class II Terminated Z-0947-2021 Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ… — Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break o…
2020-12-16 Class II Terminated Z-0944-2021 Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPI… — The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image B…
2020-10-27 Class II Terminated Z-0864-2021 All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx… — The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The i…
Filings

All 510(k) clearances (38)

Date K-number Device Code Class Specialty
2026-08-04 K262311 Alturion Series Diagnostic Ultrasound System IYN Class II Radiology
2026-07-27 K261211 Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2026-06-29 K260667 Alturion Series Diagnostic Ultrasound System IYN Class II Radiology
2026-05-27 K260680 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems IYN Class II Radiology
2026-05-27 K260123 EPIQ Series Diagnostic Ultrasound System IYN Class II Radiology
2026-05-05 K252558 Lumify Diagnostic Ultrasound System IYN Class II Radiology
2026-03-27 K253595 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2025-12-22 K252557 Lumify Diagnostic Ultrasound System IYN Class II Radiology
2025-10-09 K251651 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2025-07-24 K251455 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2025-06-18 K250886 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems IYN Class II Radiology
2025-05-21 K243793 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2025-05-15 K242519 Lumify Diagnostic Ultrasound System IYN Class II Radiology
2025-05-09 K251110 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems IYN Class II Radiology
2025-05-08 K242670 Lumify Diagnostic Ultrasound System IYN Class II Radiology
2025-04-28 K250030 Flash Ultrasound System 5100 Point of Care IYN Class II Radiology
2025-04-10 K250177 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2025-02-10 K241659 Ultrasound Workspace (UWS 6.0) QIH Class II Radiology
2025-02-06 K243794 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2024-12-12 K242020 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2024-11-15 K242800 The 5000 Compact Series Ultrasound Systems IYN Class II Radiology
2024-10-07 K240980 EPIQ Series Diagnostic Ultrasound System IYN Class II Radiology
2024-04-24 K240850 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems IYN Class II Radiology
2024-02-13 K233788 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2023-11-30 K233545 EPIQ Series Diagnostic Ultrasound System IYN Class II Radiology
2023-10-26 K232500 Lumify Diagnostic Ultrasound System IYN Class II Radiology
2023-05-12 K231190 EPIQ Series Diagnostic Ultrasound System IYN Class II Radiology
2023-05-04 K223771 Lumify Diagnostic Ultrasound System IYN Class II Radiology
2023-01-18 K223804 PercuNav Image Fusion and Interventional Navigation System JAK Class II Radiology
2022-09-27 K222648 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) IYN Class II Radiology
2021-09-24 K212777 Collaboration Live LLZ Class II Radiology
2021-02-23 K203406 Lumify Diagnostic Ultrasound System IYN Class II Radiology
2020-09-20 K200603 AAA Model LLZ Class II Radiology
2020-09-15 K201665 Collaboration Live LLZ Class II Radiology
2020-09-02 K202216 EPIQ Series Diagnostic Ultrasound Systems IYN Class II Radiology
2020-05-14 K201053 PercuNav Image Fusion and Interventional Navigation JAK Class II Radiology
2020-05-01 K201012 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System IYN Class II Radiology
2020-03-06 K200304 EPIQ Diagnostic Ultrasound System IYN Class II Radiology
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence