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 1, 2011K112213VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
GE Healthcare
IYN
Aug 29, 2011K112339ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Jul 26, 2011K111582LOGIQ S8
GE Healthcare
IYN
Jul 22, 2011K111302MYLABSEVEN, MYLABALPHA
Esaote, S.p.A.
IYN
Jul 22, 2011K110943LOGIQ E9
GE Healthcare
IYN
Jul 15, 2011K111864E-CUBE 9
Alpinion Medical Systems Co., Ltd.
IYN
Jun 30, 2011K111674ACUSON
Siemens Medical Solutions USA, Inc.
IYN
Jun 30, 2011K102813EZONO 3000
Life-Tech, Inc.
IYN
Jun 24, 2011K111513CX50 DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN
May 16, 2011K110510S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Sonoscape Company Limited, CN
IYN
May 13, 2011K111227ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Apr 15, 2011K110841DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER
Shantou Institute of Ultrasonic Instruments (Siui, CN
IYN
Mar 18, 2011K110482PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
Teratech Corp.
IYN
Mar 14, 2011K103471UBM PLUS
Accutome, Inc.
IYN
Mar 9, 2011K103649VOLUSON S6, VOLUSON S8
GE Healthcare
IYN
Mar 4, 2011K102642SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO
Sonoscape Company Limited
IYN
Feb 25, 2011K103397ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Feb 17, 2011K110207ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Feb 8, 2011K110199DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Feb 8, 2011K101236VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM
GE Healthcare
IYN
Feb 4, 2011K101312NUVUE COLORMARK9TM) NEEDLE
Nuvue Therapeutics, Inc.
IYN
Jan 31, 2011K103677M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jan 12, 2011K103144DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
Shantou Institute of Ultrasonic Instruments (Siui
IYN
Jan 7, 2011K1031526250 ULTRASOUND SYTEMS
Esaote, S.p.A.
IYN
Dec 27, 2010K103583DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Dec 21, 2010K102997SONIXTABLET ULTRASOUND SCANNER
Ultrasonix Medical Corporation, CA
IYN
Dec 9, 2010K102989OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
Chang Gung Medical Technology Co., Ltd. Linkou Fac
IYN
Nov 19, 2010K102390SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
Sonosite,Inc.
IYN
Nov 19, 2010K100598PENRITH ELETTRA ULTRASOUND SYSTEM
Penrith Corporation
IYN
Nov 4, 2010K102388VIVID I DIAGNOSTIC ULTRASOUND SYSTEM
Ge Medical System Israel , Ltd.
IYN
Oct 27, 2010K102901HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER
Hitachi Medical Systems America, Inc.
IYN
Oct 19, 2010K102023DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C
Shantou Institute of Ultrasonic Instruments (Siui
IYN
Oct 5, 2010K102256GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND
Ge Medical Systems China Co., Ltd., CN
IYN
Oct 5, 2010K101874GE LOGIQ P6/P6 PRO
GE Healthcare
IYN
Oct 1, 2010K102104GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Wipro GE Healthcare Private, Ltd.
IYN
Sep 20, 2010K102017SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Aug 31, 2010K101878GE LOGIQ P5 MODEL H44662LD
GE Healthcare
IYN
Aug 31, 2010K101605MYLABONE ULTRASOUND SYSTEM
Esaote Europe B.V.
IYN
Aug 12, 2010K102113GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
Ge Medical Systems China Co., Ltd., CN
IYN
Aug 6, 2010K102065SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Jul 19, 2010K101455EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Jun 25, 2010K101091Z.ONE ULTRA ULTRASOUND SYSTEM
Zonare Medical Systems, Inc.
IYN
Jun 25, 2010K100989ZURA TEE SYSTEM WITH CLARITEE PROBE
Imacor, Inc.
IYN
Jun 25, 2010K100931MYLABTWICE, MODEL 6200
Esaote, S.p.A.
IYN
Jun 17, 2010K093395OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
Olympus Medical Systems Corporation
IYN
May 5, 2010K100830M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Mar 24, 2010K100186MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd.
IYN
Mar 12, 2010K092922SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER
Sonoscape Company Limited
IYN
Mar 5, 2010K100402SITE-RITE VISION ULTRASOUND SYSTEM
Bard Access Systems, Inc.
IYN
Mar 5, 2010K092907DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR
Shantou Institute of Ultrasonic Instuments
IYN

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