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 4, 2024K232808Butterfly iQ3 Ultrasound System
Butterfly Network, Inc.
IYN
Dec 22, 2023K233734Interson USB Ultrasound System
Interson Corporation
IYN
Dec 21, 2023K233112HM70 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 20, 2023K231354Pocket Ultrasound System (C10)
Beijing Konted Medical Technology Co.,Ltd, CN
IYN
Dec 7, 2023K232381LOGIQ Totus
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Dec 6, 2023K233597Sonosite LX Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Nov 30, 2023K233545EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Nov 29, 2023K2301796440 MyLabX90
Esaote, S.p.A., IT
IYN
Nov 21, 2023K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation, JP
IYN
Nov 20, 2023K231941ARIETTA x10
FUJIFILM Healthcare Americas Corporation
IYN
Nov 7, 2023K231989LOGIQ E10s, LOGIQ Fortis
Ge Medical Systems Ultrasound and Primary Care Diagnostic,
IYN
Nov 7, 2023K231966LOGIQ E10
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Nov 3, 2023K232186LOGIQ e
Ge Medical Systems Ultrasound and Primary Care Diagnostic,
IYN
Oct 30, 2023K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
IYN
Oct 30, 2023K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Oct 26, 2023K232500Lumify Diagnostic Ultrasound System
Philips Ultrasound
IYN
Oct 26, 2023K231685TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Oct 24, 2023K231509Aco Apache Ultrasound System
Aco Healthcare Co., Ltd., TW
IYN
Oct 23, 2023K231764Ultrasound System 1300
Bk Medical Aps, DK
IYN
Oct 5, 2023K232704Clarius Ultrasound Scanner
Clarius Mobile Health Corp., CA
IYN
Oct 3, 2023K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 26, 2023K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Sep 26, 2023K232336ES Series V2
E-Scopics, FR
IYN
Sep 15, 2023K230066Carnation series Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technology Co. , Ltd., CN
IYN
Aug 15, 2023K231301Vscan Air
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jul 25, 2023K230365Sonio Detect
Sonio, FR
IYN
Jun 23, 2023K230160VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E
Vinno Technology (Suzhou) Co.,Ltd, CN
IYN
Jun 20, 2023K230346Voluson SWIFT; Voluson SWIFT+
Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC
IYN
Jun 17, 2023K223920VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VI
Vinno Technology (Suzhou) Co.,Ltd, CN
IYN
Jun 17, 2023K223917VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
Vinno Technology (Suzhou) Co.,Ltd, CN
IYN
Jun 9, 2023K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
May 12, 2023K231190EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
May 4, 2023K223771Lumify Diagnostic Ultrasound System
Philips Ultrasound
IYN
Apr 21, 2023K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Apr 17, 2023K223564X-CUBE 50, X-CUBE 60
Alpinion Medical Systems Co., Ltd., KR
IYN
Apr 11, 2023K223830Ultrasound System 2300
Bk Medical Aps, DK
IYN
Mar 31, 2023K223570SonoAir Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., Ltd., CN
IYN
Mar 31, 2023K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0
Canon Medical Systems Corporation, JP
IYN
Feb 16, 2023K223832Vivid S60N, Vivid S70N
Ge Medical System Ultrasound and Primary Care Diagnostics
IYN
Feb 15, 2023K223407Versana Essential
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Feb 13, 2023K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Feb 13, 2023K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 10, 2023K222596S90 Exp Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Feb 7, 2023K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ N
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Feb 6, 2023K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Dec 21, 2022K221911VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
Vinno Technology (Suzhou) Co.,Ltd, CN
IYN
Dec 7, 2022K222441Ultrasound System 2300
Bk Medical Aps, DK
IYN
Nov 11, 2022K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
Imsonic Medical China, Inc., CN
IYN
Nov 9, 2022K222754ViewMate Multi Ultrasound System
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., CN
IYN
Nov 9, 2022K222198Exo Iris (El2001)
Exo Imaging, Inc.
IYN

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