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
Oct 10, 2014K142160LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
GE Healthcare
IYN
Oct 3, 2014K142466UGEO PT60A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 12, 2014K142077MYLABGAMMA
Esaote, S.p.A.
IYN
Sep 12, 2014K142008MYLABSEVEN, MYLABALPHA
Esaote, S.p.A.
IYN
Aug 22, 2014K142017X-PORTE ULTRASOUND SYSTEM
FUJIFILM Sonosite, Inc.
IYN
Aug 7, 2014K141870BREAST VOLUME NAVIGATOR
Metritrack, LLC
IYN
Aug 7, 2014K141846ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Aug 4, 2014K141768LOGIQ V5/LOGIQ V3
GE Healthcare
IYN
Jul 25, 2014K141675VOLUSON P6, VOLUSON P8
GE Healthcare
IYN
Jul 18, 2014K141641ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM
Zonare Medical Systems, Inc.
IYN
Jul 18, 2014K141639VOLUSON S6, VOLUSON S8
GE Healthcare
IYN
Jul 11, 2014K141486MYLABSIX ULTRASOUND SYSTEM
Esaote Europe B.V., NL
IYN
Jul 2, 2014K141620RS80A DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Jul 2, 2014K141369VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Jun 16, 2014K140443ARIETTA 60/ARIETTAS60/ARIETTAV60
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
IYN
Jun 5, 2014K141261LOGIQ S7 EXPERT, LOGIQ S7 PRO
GE Healthcare
IYN
Jun 2, 2014K140364CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
Chison Medical Imaging Co., Ltd.
IYN
May 30, 2014K140773TERASON USMART3300 ULTRASOUND SYSTEM
Teratech Corp.
IYN
May 23, 2014K141067VIVID T8/VIVID T8 PRO
GE Healthcare
IYN
May 23, 2014K140729APLIO ARTIDA, V3.2
Toshiba America Medical Systems, In.C
IYN
May 16, 2014K140693VSCAN WITH DUAL PROBE
Ge Medical Sysyems Ultrasound & Primary Care Diagn
IYN
May 14, 2014K141010M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 30, 2014K140959ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
Siemens Medical Solutions USA, Inc.
IYN
Apr 25, 2014K140834TERASON USMART3400 ULTRASOUND SYSTEM
Teratech Corp.
IYN
Apr 25, 2014K140677MYLABSSOGNO
Esaote, S.p.A.
IYN
Apr 22, 2014K133761APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
Toshibamedical Systems Corporation
IYN
Apr 16, 2014K140639PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Hitachi Aloka Medical, Ltd.
IYN
Apr 15, 2014K1339056200 / 6250 ULTRASOUND SYSTEM
Esaote, S.p.A.
IYN
Mar 28, 2014K134016ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
IYN
Mar 21, 2014K140524TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
Teratech Corp.
IYN
Mar 6, 2014K140153VENTRIPOINT MEDICAL SYSTEM
Ventripoint, Inc.
IYN
Feb 26, 2014K140254EZONO 4000
Ezono AG, DE
IYN
Feb 25, 2014K132690UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
Qisda Corporation
IYN
Feb 19, 2014K140030DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Feb 12, 2014K133533LOGIQ E
GE Healthcare
IYN
Jan 31, 2014K133034LOGIQ F SERIES
GE Healthcare
IYN
Jan 17, 2014K133833NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Jan 17, 2014K133277XARIO 100
Toshibamedical Systems Corporation
IYN
Jan 10, 2014K132335ULTRASOUND SCANNER FLEX FOCUS 1202
B-K Medical Aps, DK
IYN
Jan 7, 2014K132677ULTRASOUND SCANNER FLEX FOCUS 1202
B-K Medical Aps, DK
IYN
Jan 6, 2014K132685ULTRASOUND SCANNER PRO FOCUS 2202
B-K Medical Aps, DK
IYN
Dec 27, 2013K133505SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Dec 24, 2013K133431VENUE 50
GE Healthcare
IYN
Dec 24, 2013K131164ACUSON
Siemens Medical Solutions USA, Inc.
IYN
Dec 16, 2013K133454SONOSITE EDGE ULTRASOUND SYSTEM
FUJIFILM Sonosite, Inc.
IYN
Dec 4, 2013K132466MYLABSEVEN 6400, MYLABALPHA 7400
Esaote, S.p.A.
IYN
Nov 27, 2013K133329UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Nov 27, 2013K132687E-CUBE 7
Alpinion Medical Systems Co., Ltd., KR
IYN
Nov 27, 2013K132231MYLABSEVEN, MYLABALPHA
Esaote, S.p.A.
IYN
Nov 19, 2013K132779DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN

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