ClearanceBrief
Panels › Radiology › Product code IYO · Class 2

System, Imaging, Pulsed Echo, Ultrasonic

Regulation 892.1560

11510(k)s in 12 months (898 all time)
9recalls in 12 months (83 all time)
80recalls that name a 510(k)
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Top companies in IYO

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.3111
Volcano Corporation1917
CIVCO Medical Instruments Co., Inc.717
General Electric Co.210
Advanced Technology Laboratories, Inc.200
Hewlett-Packard Co.140
GE Medical Systems112
Ausonics Pty , Ltd.120
Hitachi Medical Corp. of America120
Toshiba Medical Systems120
Decided510(k)Device and applicantCode
Sep 9, 2014K142395SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
Siemens Medical Solutions USA, Inc.
IYO
May 30, 2014K140428ULTRASOUND SCANNER SYSTEM BK2300
B-K Medical Aps, DK
IYO
May 5, 2014K140899HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
Halo Medical Technologies, LLC
IYO
Apr 1, 2014K140199VUPAD
Sonomed, Inc.
IYO
Mar 14, 2014K133323VOLCANO IFR MODALITY
Volcano Corporation
IYO
Mar 11, 2014K132736ACCURO 3000 ULTRASOUND SCANNER
Rivanna Medical, LLC
IYO
Mar 7, 2014K140291VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
Volcano Corporation
IYO
Mar 4, 2014K140126SONIC WINDOW
Analogic Corporation
IYO
Jan 10, 2014K132346ULTRASOUND SCANNER PRO FOCUS 2202
B-K Medical Aps, DK
IYO
Dec 20, 2013K133641CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
Volcano Corporation
IYO
Dec 19, 2013K123209SOFTVUE
Delphinus Medical Technologies, Inc.
IYO
Nov 15, 2013K133142VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
Volcano Corporation
IYO
Sep 26, 2013K132654ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc. Ultrasound Gro
IYO
Sep 17, 2013K131830DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Edan Instruments, Inc., CN
IYO
Aug 20, 2013K132228UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYO
Jul 24, 2013K131690M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYO
Jul 12, 2013K131227PADSCAN HD SERIES BLADDER SCANNER
Carenoso Technology Co., Ltd., CN
IYO
Jun 25, 2013K131489TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
Tractus Corporation
IYO
Jun 7, 2013K130944ISR'OBOT MONA LISA
Biobot Surgical Pte., Ltd., SG
IYO
May 3, 2013K121243ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
MEDA Co., Ltd.
IYO
Apr 5, 2013K123806FIBROSCAN
Echosens
IYO
Mar 20, 2013K130229PALM BLADDER SCANNER
Mianyang Meike Electronic Equipment Co., Ltd., CN
IYO
Mar 1, 2013K130243ILAB ULTRASOUND IMAGING SYSTEM
Boston Scientific Corp
IYO
Jan 29, 2013K123349A-SCAN PLUS CONNECT
Accutome, Inc.
IYO
Jan 15, 2013K123535ILAB ULTRASOUND IMAGING SYSTEM
Boston Scientific Corp
IYO
Jan 14, 2013K123898VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
Volcano Corporation
IYO
Dec 21, 2012K123616PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
Sonoscape Company Limited, CN
IYO
Nov 2, 2012K123185DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYO
Oct 12, 2012K122574DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6
Edan Instruments, Inc., CN
IYO
Sep 19, 2012K121689VITASCAN LT SCANMASTER
Vitacon Medical, Inc., CA
IYO
Sep 13, 2012K121479AIM
Inneroptic Technology, Inc.
IYO
Aug 16, 2012K121422APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
Toshiba Medical Systems Coporation, Japan
IYO
Jul 26, 2012K121888E-CUBE 15
Alpinion Medical Systems Co., Ltd., KR
IYO
Jun 13, 2012K111818SONIXGPS NEEDLE SENSOR
Ultrasonix Medical Corporation, CA
IYO
Jun 7, 2012K121381VIEWFLEX XTRA ICE CATHETER
St Jude Medical
IYO
May 30, 2012K120882SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
Bard Access Systems, Inc.
IYO
Apr 19, 2012K120201GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Ge Vingmed Ultrasound AS
IYO
Mar 23, 2012K113304BLADDER SCANNER
MEDA Co., Ltd.
IYO
Jan 30, 2012K112539CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
Leiker Regulatory & Quality Consulting
IYO
Jan 27, 2012K113486VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
Volcano Corporation
IYO
Jan 25, 2012K113632DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
IYO
Dec 29, 2011K113680SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
Soma Access Systems, LLC
IYO
Nov 28, 2011K113153DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
IYO
Nov 15, 2011K113156SONOSITE EDGE ULTRASOUND SYSTEM
Sonosite,Inc.
IYO
Sep 22, 2011K112022DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Advanced Instrumentations, Inc.
IYO
Aug 12, 2011K111347ISROBOT MONA LISA
Biobot Surgical Pte., Ltd.
IYO
Jul 15, 2011K111706VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
Volcano Corporation
IYO
Jul 8, 2011K111435DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
IYO
Jun 2, 2011K110688MYLABGOLD
Esaote
IYO
Mar 14, 2011K102253ECHO BLASTER
Telemed, LT
IYO

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