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 9, 2020K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Nov 4, 2020K202422Arietta 65
Hitachi Healthcare Americas
IYN
Oct 30, 2020K202556HS30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Oct 30, 2020K201988T-Lite
Sonoscanner, FR
IYN
Oct 22, 2020K201768Voluson E10
GE Healthcare
IYN
Oct 16, 2020K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound Syste
Canon Medical Systems Corporation, JP
IYN
Oct 15, 2020K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ult
Siemens Medical Solutions USA, Inc.
IYN
Oct 15, 2020K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
Canon Medical Systems Corporation, JP
IYN
Oct 11, 2020K201828Voluson SWIFT, Voluson SWIFT+
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Oct 8, 2020K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
Canon Medical Systems Corporation, JP
IYN
Sep 16, 2020K202406Butterfly iQ Ultrasound System
Butterfly Network, Inc.
IYN
Sep 9, 2020K200851Vivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Sep 9, 2020K200708Vivid iq
Ge Medical Systems Ultrasound And
IYN
Sep 2, 2020K202216EPIQ Series Diagnostic Ultrasound Systems
Philips Ultrasound, Inc.
IYN
Sep 1, 2020K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultraso
FUJIFILM Sonosite, Inc.
IYN
Aug 21, 2020K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Aug 5, 2020K200780XBit Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., Ltd., CN
IYN
Jul 30, 2020K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Jul 24, 2020K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jul 23, 2020K200743Vivid E80/ Vivid E90/ Vivid E95
Ge Medical Systems Ultrasound And
IYN
Jul 16, 2020K200497Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jul 10, 2020K200450X-Cube 70
Alpinion Medical Systems Co., Ltd., KR
IYN
Jul 10, 2020K200449X-Cube 90
Alpinion Medical Systems Co., Ltd., KR
IYN
Jul 2, 2020K201633Terason uSmart 3200T Plus Ultrasound System
Teratech Corporation
IYN
Jul 1, 2020K200138Versana Premier
Ge Medical Systems Ultrasound And
IYN
Jun 24, 2020K201462ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jun 11, 2020K200998Versana Active
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
May 28, 2020K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
May 26, 2020K201130ACUSON Juniper Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
May 21, 2020K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
May 8, 2020K200964Sonosite PX Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
May 7, 2020K200699HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
May 1, 2020K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound Syste
Philips Ultrasound, Inc.
IYN
Apr 22, 2020K200585Acuson SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Apr 17, 2020K200158LOGIQ E10
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Apr 15, 2020K200707ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Apr 10, 2020K200644ACUSON Freestyle Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Apr 9, 2020K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 8, 2020K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 7, 2020K200339HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Apr 2, 2020K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 1, 2020K200119LOGIQ E10s
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Mar 26, 2020K193518KOSMOS
EchoNous, Inc.
IYN
Mar 12, 2020K192388SonoVision Ultrasound Imaging System
Tissue Differentiation Intelligence, LLC
IYN
Mar 6, 2020K200304EPIQ Diagnostic Ultrasound System
Philips Ultrasound, Inc.
IYN
Feb 12, 2020K191235Leltek Ultrasound Imaging System
Leltek, Inc., TW
IYN
Feb 7, 2020K191347Paragon XHD Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technology Co. , Ltd., CN
IYN
Jan 31, 2020K193257ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jan 28, 2020K193510Terason uSmart3200T Ultrasound System
Teratech Corporation
IYN
Jan 23, 2020K190120VINNO 8, VINNO 6, VINNO 5
Vinno Technology (Suzhou) Co.,Ltd, CN
IYN

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