Chrysalis Intelligence · Product Codes · IYN

IYN · System, Imaging, Pulsed Doppler, Ultrasonic

Radiology · 343 clearances · 79 unique sponsors

Device class
Class II
Regulation 892.1550
Total clearances
343
2020-01-06 → 2026-08-07
Last 12 months
57
Unique sponsors
79
Medical specialty
Radiology
Review panel
RA
Regulation number
892.1550
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
GE Medical Systems Ultrasound and Primary Care Diagnostics 45 9 2026-08-07
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 36 6 2026-05-11
Philips Ultrasound, LLC 32 9 2026-08-04
Samsung Medison Co., Ltd. 29 3 2026-07-28
Siemens Medical Solutions USA, Inc. 24 3 2026-06-16
Canon Medical Systems Corporation 12 2 2026-01-20
CHISON Medical Technologies Co., Ltd. 9 1 2026-05-22
Alpinion Medical Systems Co., Ltd. 8 0 2023-04-17
FUJIFILM Sonosite, Inc. 8 3 2026-03-10
Sonoscape Medical Corp. 7 2 2026-05-15
Vinno Technology (Suzhou) Co.,Ltd 6 0 2024-12-16
Esaote, S.p.A. 6 2 2026-04-06
Leltek, Inc. 5 0 2025-05-08
GE Healthcare 5 0 2022-02-17
Ge Medical Systems Ultrasound And 4 0 2022-07-22
Shenzhen Wisonic Medical Technology Co. , Ltd. 4 0 2023-09-15
Supersonic Imagine 4 0 2024-09-20
E-Scopics 4 2 2026-06-09
Edan Instruments, Inc. 4 1 2025-12-23
EchoNous, Inc. 4 0 2025-04-25
Beijing Konted Medical Technology Co.,Ltd 3 1 2026-07-23
Bk Medical Aps 3 0 2023-10-23
Qingdao Hisense Medical Equipment Co., Ltd. 3 0 2024-05-16
Butterfly Network, Inc. 3 1 2026-03-27
Clarius Mobile Health Corp. 3 0 2024-06-14
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
93320 CPT High Doppler echocardiography; standard CPT for pulsed Doppler ultrasound imaging
76999 CPT Medium Unlisted ultrasound procedure for non-cardiac pulsed Doppler applications
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-07 K261668 GE Medical Systems Ultrasound and Primary care Diagnostics, LLC Venue Go
2026-08-04 K262311 Philips Ultrasound, LLC Alturion Series Diagnostic Ultrasound System
2026-07-30 K261835 GE Medical Systems Ultrasound and Primary Care Diagnostics LOGIQ Focus
2026-07-30 K261288 IMGFAX CO., LTD. Handheld Ultrasound Scanner
2026-07-28 K261412 Samsung Medison Co., Ltd. V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;
2026-07-27 K261211 Philips Ultrasound, LLC Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
2026-07-23 K261272 Esonic Technology (Wuhan) Co., Ltd. ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system
2026-07-23 K261081 Beijing Konted Medical Technology Co.,Ltd Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
2026-06-29 K260667 Philips Ultrasound, LLC Alturion Series Diagnostic Ultrasound System
2026-06-16 K260844 Siemens Medical Solutions USA, Inc. ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
2026-06-09 K260748 E-Scopics ES-Series
2026-05-27 K260680 Philips Ultrasound, LLC EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
2026-05-27 K260123 Philips Ultrasound, LLC EPIQ Series Diagnostic Ultrasound System
2026-05-26 K260398 GE Medical Systems Ultrasound and Primary Care Diagnostics LOGIQ e
2026-05-22 K253949 CHISON Medical Technologies Co., Ltd. SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
2026-05-21 K253720 Wuhan United Imaging Healthcare Co.,Ltd uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
2026-05-15 K254028 Sonoscape Medical Corp. Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)
2026-05-15 K253716 Wuhan United Imaging Healthcare Co.,Ltd uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super
2026-05-14 K260111 Mytech Intelligence (Shenzhen) Co., Ltd. Palmtop Ultrasound Diagnostic System (MT10P/MT10)
2026-05-11 K260846 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos
2026-05-05 K261132 Healium Intelliscan Corporation Healium Intelliscan LX192LC
2026-05-05 K252558 Philips Ultrasound, LLC Lumify Diagnostic Ultrasound System
2026-04-29 K260589 E-Scopics ES-Series
2026-04-06 K253288 Esaote, S.p.A. 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
2026-04-02 K252709 Xuzhou Yongkang Electronic Science Technology Co., Ltd. Wireless Probe Type Ultrasound Scanner