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
Nov 16, 2021K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 E
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Nov 15, 2021K213436Clarius Ultrasound Scanner
Clarius Mobile Health Corp., CA
IYN
Nov 5, 2021K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Nov 3, 2021K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)
Leltek, Inc., TW
IYN
Sep 24, 2021K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
Philips Medical Systems
IYN
Sep 16, 2021K2120216430 MyLabX75, 6430 MyLab XPro75
Esaote, S.p.A., IT
IYN
Sep 10, 2021K211488LOGIQ E10
GE Healthcare
IYN
Sep 10, 2021K210438Versana Premier
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Sep 9, 2021K211824HERA W9, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 8, 2021K211945V8 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 8, 2021K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Medical Systems
IYN
Aug 27, 2021K211524LOGIQ E10s, LOGIQ Fortis
GE Healthcare
IYN
Aug 20, 2021K211527Exo Iris
Exo Imaging, Inc.
IYN
Aug 19, 2021K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital C
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), CN
IYN
Aug 18, 2021K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), CN
IYN
Aug 9, 2021K211300X-CUBE 90
Alpinion Medical Systems Co., Ltd., KR
IYN
Aug 9, 2021K211299X-CUBE 70
Alpinion Medical Systems Co., Ltd., KR
IYN
Aug 6, 2021K212100Kosmos
EchoNous, Inc.
IYN
Jul 30, 2021K210154Labat series Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technology Co. , Ltd., CN
IYN
Jul 20, 2021K211859ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jul 9, 2021K210713HM70 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jul 1, 2021K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jun 29, 2021K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
Supersonic Imagine, FR
IYN
Jun 25, 2021K211232Apache Ultrasound System
Aco Healthcare Co., Ltd., TW
IYN
Jun 25, 2021K203657Vu-Path Ultrasound System
Crystalline Medical
IYN
Jun 24, 2021K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 10, 2021K210699Resona 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 10, 2021K210416M9/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
Jun 9, 2021K211216Vivid S60N / Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
May 13, 2021K210426HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Apr 9, 2021K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Apr 8, 2021K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Reson
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., CN
IYN
Apr 1, 2021K210743ACUSON Redwood Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Mar 23, 2021K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Mar 5, 2021K202658Vivid E80/ Vivid E90/ Vivid E95
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Mar 2, 2021K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound Syste
CHISON Medical Technologies Co., Ltd., CN
IYN
Feb 26, 2021K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
CHISON Medical Technologies Co., Ltd., CN
IYN
Feb 26, 2021K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
CHISON Medical Technologies Co., Ltd., CN
IYN
Feb 25, 2021K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
CHISON Medical Technologies Co., Ltd., CN
IYN
Feb 25, 2021K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
CHISON Medical Technologies Co., Ltd., CN
IYN
Feb 23, 2021K203406Lumify Diagnostic Ultrasound System
Philips Ultrasound, Inc.
IYN
Jan 25, 2021K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28,
Edan Instruments, Inc., CN
IYN
Jan 25, 2021K202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
Viasonix , Ltd., IL
IYN
Jan 8, 2021K203114LOGIQ P10, LOGIQ P9, LOGIQ P8
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Dec 29, 2020K203137Venue Fit
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Dec 29, 2020K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Syste
Supersonic Imagine, FR
IYN
Nov 18, 2020K202233Venue Go
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Nov 13, 2020K202132Venue
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Nov 12, 2020K202074Apache Ultrasound System (Model C62)
Compal Electronics, Inc., TW
IYN
Nov 9, 2020K203128EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
Olympus Medical Systems Corp., JP
IYN

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