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)
4recalls 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
Feb 1, 2018K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jan 12, 2018K1732916440 Ultrasound System
Esaote, S.p.A., IT
IYN
Jan 11, 2018K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
Toshibamedical Systems Corporation, JP
IYN
Jan 9, 2018K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
Supersonic Imagine, FR
IYN
Jan 8, 2018K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jan 2, 2018K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ul
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jan 2, 2018K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technology Co. , Ltd., CN
IYN
Dec 20, 2017K173555LOGIQ E10
GE Healthcare
IYN
Dec 14, 2017K172732E-CUBE 8
Alpinion Medical Systems Co., Ltd., KR
IYN
Dec 13, 2017K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., CN
IYN
Dec 12, 2017K172276Xario 200 Diagnostic Ultrasound System V6.0
Toshibamedical Systems Corporation, JP
IYN
Dec 7, 2017K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), CN
IYN
Dec 5, 2017K172993P20 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Dec 1, 2017K173058P10 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Nov 15, 2017K173003U50 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
Nov 14, 2017K170859Dolphin/IQ and Dolphin/4D
Viasonix , Ltd., IL
IYN
Nov 7, 2017K173265UltraVision 2 Diagnostic Ultrasound System
Winprobe Corporation
IYN
Nov 2, 2017K173341Vivid E80, Vivid E90, Vivid E95
GE Medical Systems
IYN
Oct 31, 2017K171708ALOKA ARIETTA 850
Hitachi Healthcare Americas Corporation
IYN
Oct 27, 2017K171926C5 Diagnostic Ultrasound System
Guangzhou Sonostar Technologies Co., Ltd., CN
IYN
Oct 25, 2017K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Oct 18, 2017K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Oct 12, 2017K170085SONON Ultrasound Imaging System, Model: 300L
Healcerion Co., Ltd., KR
IYN
Oct 5, 2017K172059LinkQuest Diagnostic Ultrasound System model SQ860
Linkquest, Inc.
IYN
Oct 4, 2017K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound Syst
Philips Health Care
IYN
Sep 29, 2017K172380U2 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
Sep 29, 2017K172342Voluson E6, Voluson E8, Voluson E10
GE Healthcare
IYN
Sep 21, 2017K172082S60 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Sep 21, 2017K171891ZS3 Ultrasound System, z.one pro Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Sep 14, 2017K172385Clarius Ultrasound System
Clarius Mobile Health Corp., CA
IYN
Sep 12, 2017K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., CN
IYN
Sep 6, 2017K163510Poseidon Ultrasound System
Butterfly Network, Inc.
IYN
Aug 31, 2017K172055DUS-7000 Digital Color Doppler Ultrasound System
Advanced Instrumentations, Inc.
IYN
Aug 24, 2017K171048RS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Aug 18, 2017K171900Acclarix AX4 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
Aug 16, 2017K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
Siemens Healthcare
IYN
Aug 15, 2017K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Aug 10, 2017K163121SmartUs EXT-1M/3M
Telemed, LT
IYN
Aug 9, 2017K171070WS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Aug 8, 2017K172129HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Aug 3, 2017K171164U-Lite EXP
Sonoscanner, FR
IYN
Jul 12, 2017K170999P50 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Jul 11, 2017K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
Supersonic Imagine, FR
IYN
Jul 11, 2017K171000P60 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Jul 10, 2017K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnosti
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jul 6, 2017K170870Site~Rite Halcyon Diagnostic Ultrasound System
Chison Medical Imaging Co., Ltd., CN
IYN
Jun 21, 2017K170714Venue
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Jun 14, 2017K170878Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Jun 12, 2017K171437SonoSite X-Porte Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Jun 12, 2017K170823Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN

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