Chrysalis Intelligence · Sponsors · GE Medical Systems Ultrasound and Primary Care Diagnostics

GE Medical Systems Ultrasound and Primary Care Diagnostics

Waukesha, WI, US · 49 510(k) clearances

Total clearances
49
2020-04-01 → 2026-08-07
Last 12 months
9
Product codes
4
Most recent
2026-08-07
Name variants in FDA filings: GE Medical Systems Ultrasound and Primary Care Diagnostics / GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
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 45 2026-08-07
QIH Automated Radiological Image Processing Software Class II Radiology 2 2025-07-16
ITX 1 2020-11-20
LLZ System, Image Processing, Radiological Class II Radiology 1 2020-09-18
Filings

All 510(k) clearances (49)

Date K-number Device Code Class Specialty
2026-08-07 K261668 Venue Go IYN Class II Radiology
2026-07-30 K261835 LOGIQ Focus IYN Class II Radiology
2026-05-26 K260398 LOGIQ e IYN Class II Radiology
2026-03-24 K260673 LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power IYN Class II Radiology
2026-01-08 K253370 LOGIQ Totus IYN Class II Radiology
2026-01-07 K253366 LOGIQ Fortis IYN Class II Radiology
2025-11-24 K252328 Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 IYN Class II Radiology
2025-10-29 K251985 LOGIQ E10 IYN Class II Radiology
2025-10-29 K251963 LOGIQ E10s IYN Class II Radiology
2025-07-25 K251322 Venue; Venue Go; Venue Fit; Venue Sprint IYN Class II Radiology
2025-07-16 K251342 EchoPAC Software Only / EchoPAC Plug-in QIH Class II Radiology
2025-07-10 K251169 Vivid Pioneer IYN Class II Radiology
2025-05-29 K250543 Voluson™ Performance 16; Voluson™ Performance 18 IYN Class II Radiology
2025-05-01 K250087 Vscan Air IYN Class II Radiology
2025-02-11 K243628 Vivid T9/Vivid T8 IYN Class II Radiology
2025-02-11 K243620 Vivid iq IYN Class II Radiology
2024-12-20 K242168 Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 IYN Class II Radiology
2024-10-02 K242005 Versana Premier; Versana Premier Lotus; LOGIQ F IYN Class II Radiology
2024-06-10 K240206 Venue Sprint IYN Class II Radiology
2024-06-10 K240111 Venue IYN Class II Radiology
2024-06-10 K240053 Venue Go IYN Class II Radiology
2024-06-10 K234106 Venue Fit IYN Class II Radiology
2024-03-07 K233692 Voluson Signature 20, Voluson Signature 18 IYN Class II Radiology
2023-12-07 K232381 LOGIQ Totus IYN Class II Radiology
2023-11-07 K231966 LOGIQ E10 IYN Class II Radiology
2023-10-30 K231965 Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 IYN Class II Radiology
2023-08-15 K231301 Vscan Air IYN Class II Radiology
2023-02-15 K223407 Versana Essential IYN Class II Radiology
2022-07-22 K220940 EchoPAC Software Only, EchoPAC Plug-in QIH Class II Radiology
2022-07-18 K221147 Vivid T8, Vivid T9 IYN Class II Radiology
2022-07-15 K220619 Vivid S60N, Vivid S70N IYN Class II Radiology
2022-06-21 K220800 Venue Go IYN Class II Radiology
2022-06-06 K220358 Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 IYN Class II Radiology
2022-05-11 K220446 Versana Balance IYN Class II Radiology
2022-03-22 K214039 LOGIQ P10, LOGIQ P9, LOGIQ P8 IYN Class II Radiology
2021-09-10 K210438 Versana Premier IYN Class II Radiology
2021-06-09 K211216 Vivid S60N / Vivid S70N IYN Class II Radiology
2021-03-05 K202658 Vivid E80/ Vivid E90/ Vivid E95 IYN Class II Radiology
2021-01-08 K203114 LOGIQ P10, LOGIQ P9, LOGIQ P8 IYN Class II Radiology
2020-12-29 K203137 Venue Fit IYN Class II Radiology
2020-11-20 K202035 Vscan Air ITX
2020-11-18 K202233 Venue Go IYN Class II Radiology
2020-11-13 K202132 Venue IYN Class II Radiology
2020-10-11 K201828 Voluson SWIFT, Voluson SWIFT+ IYN Class II Radiology
2020-09-18 K200852 EchoPAC Software Only, EchoPAC Plug-In LLZ Class II Radiology
2020-09-09 K200851 Vivid T8, Vivid T9 IYN Class II Radiology
2020-07-16 K200497 Vivid S60N, Vivid S70N IYN Class II Radiology
2020-06-11 K200998 Versana Active IYN Class II Radiology
2020-04-01 K200119 LOGIQ E10s IYN Class II Radiology