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 3, 2012K122114LOGIQ S7 EXPERT, LOGIQ S7 PRO
GE Healthcare
IYN
Oct 3, 2012K122009AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER
Panasonic Healthcare Co., Ltd.
IYN
Sep 28, 2012K122825ACUSON
Siemens Medical Solutions USA, Inc.
IYN
Sep 26, 2012K122341PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37
Hitachi Aloka Medical, Ltd.
IYN
Sep 21, 2012K122327VOLUSON E6/E8/E8EXPERT/E10
GE Healthcare
IYN
Sep 20, 2012K121729E-CUBE 7
Alpinion Medical Systems Co., Ltd.
IYN
Sep 13, 2012K122491VIAMO SSA-640A V4.0
Toshibamedical Systems Corporation
IYN
Sep 11, 2012K122387VOLUSON P6, VOLUSON P8
GE Healthcare
IYN
Sep 7, 2012K121983DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA
Benq Medical Technology Corpation
IYN
Sep 5, 2012K122583UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Aug 28, 2012K112255AIXPLORER
Supersonic Imagine, FR
IYN
Aug 24, 2012K121329AIXPLORER
Supersonic Imagine, FR
IYN
Aug 21, 2012K121063VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
Ge Medical System Israel , Ltd.
IYN
Aug 2, 2012K121867SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
Chison Medical Imaging Co., Ltd., CN
IYN
Jul 26, 2012K121937E-CUBE INNO
Alpinion Medical Systems Co., Ltd., KR
IYN
Jul 20, 2012K122010Z6 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jun 22, 2012K121699ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Jun 22, 2012K121646ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc. Ultrasound Gro
IYN
Jun 22, 2012K121577APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
Toshiba Medical Systems Corporation, Japan
IYN
Jun 15, 2012K113613DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
Shantou Institute of Ultrasonic Instuments, CN
IYN
Jun 14, 2012K120801CHISON DIAGNOSTIC ULTRASOUND SYSTEM
Chison Medical Imaging Co., Ltd.
IYN
May 23, 2012K121384MYLABSOGNO
Esaote, S.p.A.
IYN
May 17, 2012K121138ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solution
IYN
Apr 27, 2012K120741VOLUSON S6, VOLUSON S8
GE Healthcare
IYN
Apr 19, 2012K121010M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 19, 2012K120699DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 19, 2012K120234EZONO 3000
Life-Tech, Inc.
IYN
Apr 13, 2012K120703ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
Zonare Medical Systems, Inc.
IYN
Mar 16, 2012K120060E-CUBE 9
Alpinion Medical Systems Co., Ltd.
IYN
Feb 17, 2012K120321CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
Philips Health Care
IYN
Feb 10, 2012K113612AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A
Panasonic Healthcare Co., Ltd.
IYN
Feb 3, 2012K113359CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
Chison Medical Imaging Co., Ltd.
IYN
Feb 3, 2012K112953TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
Teratech Corp.
IYN
Jan 26, 2012K113184LOGICSCAN 64 LOGICSCAN 128
Telemed, LT
IYN
Jan 25, 2012K113663SONIXTABLET ULTRASOUND SCANNER
Ultrasonix Medical Corporation, CA
IYN
Dec 29, 2011K113690GE LOGIQ I, LOGIQ E AND VIVID E
GE Healthcare
IYN
Dec 29, 2011K113381MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Dec 17, 2011K112997HD-IVUS ULTRASOUND IMAGING SYSTEM
Silicon Vally Medical Instruments, Inc.
IYN
Dec 16, 2011K113647DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Dec 16, 2011K100919PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
B-K Medical Aps, DK
IYN
Dec 7, 2011K113179ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYN
Nov 7, 2011K112602S6 DIAGNOSTIC ULTRASOUND SYSTEM
Sonoscape Company Limited, CN
IYN
Oct 12, 2011K112646SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Oct 4, 2011K110870APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM
Toshiba America Medical Systems, In.C
IYN
Sep 27, 2011K112726SONIX ULTRASOUND SCANNER
Ultrasonix Medical Corporation, CA
IYN
Sep 27, 2011K112371LOGIQ P3
GE Healthcare
IYN
Sep 27, 2011K110673HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
Hitachi Medical Systems America, Inc.
IYN
Sep 23, 2011K112122VENUE 40
GE Healthcare
IYN
Sep 16, 2011K112596ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYN
Sep 16, 2011K112451S8 DIAGNOSTIC ULTRASOUND SYSTEM
Sonoscape Company Limited, CN
IYN

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