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Panels › Radiology › Product code ITX · Class 2

Transducer, Ultrasonic, Diagnostic

Regulation 892.1570

6510(k)s in 12 months (415 all time)
13recalls in 12 months (147 all time)
118recalls that name a 510(k)
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Top companies in ITX

Company510(k)sRecalls
CIVCO Medical Instruments Co., Inc.1628
Philips Ultrasound, Inc.339
Exact Medical Manufacturing218
Biosound, Inc.130
Boston Scientific102
Siemens Medical Solutions USA, Inc.75
Acuson Corp.110
General Electric Co.110
Acuson Computed Sonography100
Toshiba America Medical Systems, In.C90
Decided510(k)Device and applicantCode
Aug 17, 2012K121062VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
Ge Medical System Israel , Ltd.
ITX
Jul 10, 2012K121807V5MS TRANSDUCER
Siemens Medical Solutions USA, Inc.
ITX
Mar 6, 2012K113832SONICEYE ULTRASOUND TRANSDUCER
Blacktoe Medical Iii, Inc.
ITX
Mar 1, 2012K111426EUCLID (TM) TIER 1-GW ACCESS SYSTEM
Houston Medical Robotics
ITX
Feb 8, 2012K120156PUREIMAGE ULTRASOUND TRANSMISSION GEL
Medline
ITX
Jun 28, 2011K110752HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
Highland Instruments
ITX
May 27, 2011K101952KONIX ULTRASOUND GEL
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
ITX
Apr 27, 2011K111021CUBESCAN / BIOCON-700
Mcube Technology Co., Ltd., KR
ITX
Apr 26, 2011K110999DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Edan Instruments, Inc., CN
ITX
Apr 8, 2011K110920UF-760AG
Fukuda Denshi Co., Ltd.
ITX
Feb 8, 2011K110202FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
Fujifilm Medical System U.S.A., Inc.
ITX
Feb 2, 2011K103629PET-512MC TRANSESOPHAGEAL TRANSDUCER
Toshiba America Medical Systems, In.C
ITX
Jan 20, 2011K110020TERASON T3200 ULTRASOUND SYSTEM
Teratech Corp.
ITX
Jan 12, 2011K103645APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
Toshiba Medical Systems Corporation, Japan
ITX
Jan 5, 2011K103722THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
ITX
Nov 3, 2010K102865DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
ITX
Oct 13, 2010K102041AIXPLORER
Supersonic Imagine, FR
ITX
Aug 19, 2010K101816STN PROBE
Summit Doppler Systems, Inc.
ITX
Aug 12, 2010K101757SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM
Sonosite,Inc.
ITX
Jul 16, 2010K101829THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
ITX
Jun 8, 2010K101008DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
Shantou Institute of Ultrasonic Instruments (Siui
ITX
Apr 30, 2010K101041DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
ITX
Feb 19, 2010K100204SONALIS
Smith Associates
ITX
Jan 28, 2010K100067MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
Toshiba America Medical Systems, In.C
ITX
Jan 19, 2010K093713ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
Civco Medical Instruments
ITX
Dec 10, 2009K093714SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
ITX
Nov 20, 2009K093462SONIX ULTRASOUND SCANNER
Ultrasonix Medical Corporation, CA
ITX
Nov 10, 2009K092858SAFERSONIC SONOGRAPHY COVER
Safersonic Medizinprodukte GmbH
ITX
Oct 15, 2009K092691DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
ITX
Sep 28, 2009K092756GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
Ge Vingmed Ultrasound AS, NO
ITX
Sep 28, 2009K091828SHEATHESISO ULTRASOUND TRANSDUCER COVER
Sheathing Technologies, Inc.
ITX
Sep 24, 2009K092637PACSCAN PLUS, MODELS 300P AND 300AP
Sonomed, Inc.
ITX
Sep 2, 2009K091877CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL
Chison Medical Imaging Co., Ltd.
ITX
Jul 17, 2009K091804CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
Philips Ultrasound, Inc.
ITX
Jul 9, 2009K091941DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
ITX
Jun 19, 2009K091680DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Edan Instruments, Inc.
ITX
May 15, 2009K091295APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
Toshiba America Medical Systems, In.C
ITX
Apr 15, 2009K090912DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
ITX
Apr 8, 2009K090465DIGDOP ULTRASOUND SYSTEM
The Newman Group, LLC
ITX
Feb 10, 2009K083824HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
Humanscan Company, Ltd.
ITX
Feb 2, 2009K083667NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
B-K Medical Aps, DK
ITX
Jan 13, 2009K083877FLYING DIAGNOSTIC ULTRASOUND SYSTEM
Neusoft Medical Systems Co., Ltd., CN
ITX
Dec 15, 2008K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
Shimadzu Medical Systems
ITX
Dec 5, 2008K082893PRAGER SHELL
Esi, Inc.
ITX
Sep 9, 2008K081919UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
Fukuda Denshi Co., Ltd.
ITX
Jul 11, 2008K081802CX50 DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
ITX
Jun 11, 2008K080970USHIFU STEPPER
Ushifu Development Company, LLC
ITX
Jun 3, 2008K080555SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
Ivu Imaging Corporation
ITX
Mar 13, 2008K073623ATLANTIS 018 PERIPHERAL IMAGING CATHETER
Boston Scientific Corp
ITX
Mar 11, 2008K080272ATLANTIS PVIMAGING CATHETER, MODEL H749364560
Boston Scientific Corp
ITX

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