ClearanceBrief
Panels › Radiology › Product code IYN · Class 2

System, Imaging, Pulsed Doppler, Ultrasonic

Regulation 892.1550

55510(k)s in 12 months (1,189 all time)
10recalls in 12 months (300 all time)
288recalls that name a 510(k)
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Top companies in IYN

Company510(k)sRecalls
Philips Ultrasound5293
Siemens Medical Solutions USA, Inc.7562
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.850
Samsung Medison Co., Ltd.700
GE Healthcare5215
GE Medical Systems Ultrasound and Primary Care Diagnostics620
Esaote, S.p.A.347
Alpinion Medical Systems Co., Ltd.250
FUJIFILM Sonosite, Inc.250
General Electric Co.230
Decided510(k)Device and applicantCode
Oct 16, 2026K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Oct 8, 2026K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic U
Samsung Medison Co., Ltd., KR
IYN
Oct 8, 2026K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (R
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Oct 2, 2026K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
IYN
Sep 25, 2026K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP
Samsung Medison Co., Ltd., KR
IYN
Sep 25, 2026K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Sep 2, 2026K261313Vivid Explorer/Vivid Advanced/Vivid Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Aug 24, 2026K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 9
Sonoscape Medical Corp., CN
IYN
Aug 7, 2026K261668Venue Go
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
IYN
Aug 4, 2026K262311Alturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jul 30, 2026K261835LOGIQ Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jul 30, 2026K261288Handheld Ultrasound Scanner
IMGFAX CO., LTD., CN
IYN
Jul 28, 2026K261412V8/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/H
Samsung Medison Co., Ltd., KR
IYN
Jul 27, 2026K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jul 23, 2026K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagn
Esonic Technology (Wuhan) Co., Ltd., CN
IYN
Jul 23, 2026K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
Beijing Konted Medical Technology Co.,Ltd, CN
IYN
Jun 29, 2026K260667Alturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jun 16, 2026K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic
Siemens Medical Solutions USA, Inc.
IYN
Jun 9, 2026K260748ES-Series
E-Scopics, FR
IYN
May 27, 2026K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
IYN
May 27, 2026K260123EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
May 26, 2026K260398LOGIQ e
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
May 22, 2026K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, S
CHISON Medical Technologies Co., Ltd., CN
IYN
May 21, 2026K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
Wuhan United Imaging Healthcare Co.,Ltd, CN
IYN
May 15, 2026K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra
Sonoscape Medical Corp., CN
IYN
May 15, 2026K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse P
Wuhan United Imaging Healthcare Co.,Ltd, CN
IYN
May 14, 2026K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)
Mytech Intelligence (Shenzhen) Co., Ltd., CN
IYN
May 11, 2026K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ul
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
May 5, 2026K261132Healium Intelliscan LX192LC
Healium Intelliscan Corporation
IYN
May 5, 2026K252558Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Apr 29, 2026K260589ES-Series
E-Scopics, FR
IYN
Apr 6, 2026K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote, S.p.A., IT
IYN
Apr 2, 2026K252709Wireless Probe Type Ultrasound Scanner
Xuzhou Yongkang Electronic Science Technology Co., Ltd., CN
IYN
Mar 27, 2026K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ
Samsung Medison Co., Ltd., KR
IYN
Mar 27, 2026K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Mar 27, 2026K252148Butterfly Gestational Age Tool
Butterfly Network, Inc.
IYN
Mar 24, 2026K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 E
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Mar 16, 2026K252433Sonio Detect (v3)
Sonio, FR
IYN
Mar 10, 2026K260595Sonosite iLOOK Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Feb 11, 2026K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Reso
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jan 20, 2026K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation, JP
IYN
Jan 8, 2026K253370LOGIQ Totus
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jan 7, 2026K253366LOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jan 5, 2026K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R
Samsung Medison Co., Ltd., KR
IYN
Dec 23, 2025K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
Edan Instruments, Inc., CN
IYN
Dec 22, 2025K252557Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Dec 22, 2025K250959BioticsAI
Bioticsai, Inc.
IYN
Dec 5, 2025K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plu
Sonoscape Medical Corp., CN
IYN
Dec 4, 2025K250791ASUS Ultrasound Imaging System (LU800 series)
Asustek Computer, Inc., TW
IYN
Dec 3, 2025K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibro
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN

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