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
Sep 3, 2015K152396S12 Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Sep 3, 2015K152250SpeqRT
Signostics Limited, AU
IYN
Sep 3, 2015K142982OPUS 5100 Diagnostic Doppler Ultrasound System
Chang Gung Medical Technology Co., Ltd., TW
IYN
Aug 28, 2015K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Aug 26, 2015K152165S9 Portable Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Aug 19, 2015K152209FUJIFILM SonoSite X-Porte Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Aug 12, 2015K151663RS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jul 28, 2015K150861QBit Series Diagnostic Ultrasound System
Chison Medical Imaging Co., Ltd., CN
IYN
Jul 23, 2015K150773E-CUBE 15 Diagnostic Ultrasound System
Alpinion Medical Systems Co., Ltd., KR
IYN
Jul 23, 2015K141720iuStar300 Medical Ultrasound Diagnostic System
United Imaging Systems (Beijing) Co., Ltd.
IYN
Jul 9, 2015K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0
Toshibamedical Systems Corporation, JP
IYN
Jun 23, 2015K150002iNSIGHT Color Doppler Ultrasound System
Saset (Chengdu), Inc., CN
IYN
Jun 23, 2015K143476Digi-One
Rimed , Ltd., IL
IYN
Jun 18, 2015K151028LOGIQ e
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jun 12, 2015K150080DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
May 22, 2015K150628VentriPoint Medical System
Ventripoint, Inc.
IYN
May 15, 2015K151175ZONARE ZS3 Diagnostic Ultrasound System
Zonare Medical Systems, Inc.
IYN
May 9, 2015K150533Terason uSmart3200T Ultrasound System
Teratech Corp.
IYN
Apr 28, 2015K150045S30/S40 Digital Color Doppler Ultraound System
Sonoscape Company Limited, CN
IYN
Apr 10, 2015K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Mar 26, 2015K150478A35 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Mar 18, 2015K143601U-Lite
Sonoscanner Sarl, FR
IYN
Mar 4, 2015K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
Zonare Medical Systems, Inc.
IYN
Mar 4, 2015K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ult
Ge Vingmed Ultrasound AS, NO
IYN
Feb 20, 2015K150148Terason uSmart3300 Ultrasound System
Teratech Corp.
IYN
Feb 20, 2015K142511U50 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
Feb 10, 2015K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
GE Healthcare
IYN
Feb 9, 2015K150050ACUSON P500 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jan 29, 2015K143452LOGIQ P9, LOGIQ P7
GE Healthcare
IYN
Jan 29, 2015K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
Sonoscape Company Limited, TW
IYN
Jan 28, 2015K142815S22 Digital Color Doppler Ultrasound System
Sonoscape Company Limited, CN
IYN
Jan 16, 2015K143298Ultrasound Scanner System bk2300
Bk Medical Aps, DK
IYN
Jan 14, 2015K142368NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
Hitachi Aloka Medical, Ltd.
IYN
Jan 5, 2015K142710S9 Portable Digital Color Doppler Ultrasound System
Sonoscape Company Limited, TW
IYN
Jan 2, 2015K143472TE7 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Dec 19, 2014K142474S12 Digital Color Doppler Ultrasound System
Sonoscape Company Limited, CN
IYN
Dec 9, 2014K143264H60 V2.00 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Nov 26, 2014K143089WS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Nov 21, 2014K142197ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
Konica Minolta, Inc., JP
IYN
Nov 20, 2014K143027Xario 200, V3.0
Toshibamedical Systems Corporation, JP
IYN
Nov 20, 2014K142100AIXPLORER
Supersonic Imagine, FR
IYN
Nov 19, 2014K143046Xario 100, V3.0
Toshibamedical Systems Corporation, JP
IYN
Nov 19, 2014K141462VARIA-NCI
Neurochaos Solutions, Inc.
IYN
Nov 18, 2014K131973UNEXEF-38G ULTRASOUND SYSTEM
Toyota Tsusho Corporation
IYN
Oct 28, 2014K142884E-CUBE 12
Alpinion Medical Systems Co., Ltd., KR
IYN
Oct 28, 2014K142733E-CUBE 5
Alpinion Medical Systems Co., Ltd., KR
IYN
Oct 28, 2014K141459APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0
Toshibamedical Systems Corporation
IYN
Oct 23, 2014K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
Siemens Medical Solutions USA, Inc.
IYN
Oct 10, 2014K142628Acuson SC2000 Diagnostic Ultrasound System
Siemens Medi Cal Solutions, Inc.
IYN
Oct 10, 2014K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
Ge Medical Systems Israel , Ltd., IL
IYN

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