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
Jan 17, 2025K241949Digital Color Doppler Ultrasound System (P60 Series)
Sonoscape Medical Corp., CN
IYN
Dec 20, 2024K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Dec 16, 2024K240676ULTIMUS Series Ultrasound Diagnostic System
Vinno Technology (Suzhou) Co.,Ltd, CN
IYN
Dec 12, 2024K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Dec 10, 2024K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius
Shantou Institute of Ultrasonic Instruments Co., Ltd., CN
IYN
Dec 10, 2024K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultra
Samsung Medison Co., Ltd., KR
IYN
Nov 27, 2024K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Nov 19, 2024K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
IYN
Nov 15, 2024K243299ACUSON Redwood Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Nov 15, 2024K242800The 5000 Compact Series Ultrasound Systems
Philips Ultrasound, LLC
IYN
Nov 8, 2024K242231Resona 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
Oct 24, 2024K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
Telefield Medical Imaging (Shenzhen) Limited, CN
IYN
Oct 11, 2024K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Oct 7, 2024K240980EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Oct 2, 2024K242005Versana Premier; Versana Premier Lotus; LOGIQ F
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Sep 20, 2024K242223SuperSonic HepaVu
Supersonic Imagine, FR
IYN
Sep 18, 2024K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
Edgelife Technologies, LLC
IYN
Sep 16, 2024K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/A
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Sep 12, 2024K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Canon Medical Systems Corporation, JP
IYN
Sep 12, 2024K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Sep 11, 2024K241380FETOLY-HEART
Diagnoly, FR
IYN
Sep 11, 2024K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound
Leltek, Inc., TW
IYN
Aug 30, 2024K241051Vave Wireless Ultrasound System
Vave Health, Inc.
IYN
Aug 29, 2024K233826Kosmos
EchoNous, Inc.
IYN
Aug 22, 2024K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
Beijing Konted Medical Technology Co.,Ltd, CN
IYN
Aug 9, 2024K233697SonoMax Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., Ltd., CN
IYN
Jul 23, 2024K240906TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jul 22, 2024K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
IYN
Jun 21, 2024K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 17, 2024K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imag
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jun 14, 2024K233955Clarius OB AI
Clarius Mobile Health Corp., CA
IYN
Jun 12, 2024K240516RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 12, 2024K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jun 10, 2024K240206Venue Sprint
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jun 10, 2024K240111Venue
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jun 10, 2024K240053Venue Go
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jun 10, 2024K234106Venue Fit
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
May 16, 2024K233841HD80 Series Ultrasound Diagnostic System
Qingdao Hisense Medical Equipment Co., Ltd., CN
IYN
May 2, 2024K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
Contec Medical Systems Co.,Ltd, CN
IYN
Apr 26, 2024K240406Sonio Detect
Sonio, FR
IYN
Apr 24, 2024K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
IYN
Apr 22, 2024K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Mar 22, 2024K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)
Guangdong Youkey Medical Co., Ltd., CN
IYN
Mar 7, 2024K233692Voluson Signature 20, Voluson Signature 18
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Feb 21, 2024K233439HD60 Series Ultrasound Diagnostic System
Qingdao Hisense Medical Equipment Co., Ltd., CN
IYN
Feb 15, 2024K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert
Medisono
IYN
Feb 13, 2024K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jan 28, 2024K233394Gem Flow Now (GEM2770-FN)
Synovis Micro Companies Alliance
IYN
Jan 24, 2024K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
Canon Medical Systems Corporation, JP
IYN
Jan 11, 2024K232285U-Lite PRO
Sonoscanner Sarl, FR
IYN

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