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
Mar 11, 2011K103148AIDA DIAGNOSTIC ULTRASOUND SYSTEM
Panasonic Healthcare Co., Ltd.
IYO
Jan 20, 2011K102153MOBIUS ULTRASOUND IMAGING SYSTEM
Mobisante, Inc.
IYO
Dec 27, 2010K103608I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
Ellex, Inc.
IYO
Dec 22, 2010K102027AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
Quantel Medical S.A.
IYO
Nov 5, 2010K102393VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM
Ge Medical System Israel , Ltd.
IYO
Nov 5, 2010K102198COMPACT TOUCH STS
Quantel Medical S.A.
IYO
Oct 22, 2010K102991M5 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYO
Oct 13, 2010K101149GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Ge Vingmed Ultrasound AS
IYO
Sep 30, 2010K101337A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
Sonoscape Company Limited, CN
IYO
Sep 15, 2010K101429ECO SUPERGEL
Ceracarta Spa
IYO
Jun 17, 2010K093466HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
Hitachi Medical Systems America, Inc.
IYO
May 21, 2010K100363ULTRA DCI MODEL 5000
Ultrasound Medical Devices, Inc.
IYO
Apr 22, 2010K094038COMPACT TOUCH
Quantel S.A.
IYO
Apr 9, 2010K100252MASTER-VU A-SCAN, MV4500
Sonomed, Inc.
IYO
Apr 5, 2010K093371MODEL DGH 6000 SCANMATE A
Dgh Technology, Inc.
IYO
Mar 16, 2010K093485VESISCAN
Life-Tech, Inc.
IYO
Mar 1, 2010K100079DIGITAL ULTRASOUND SCANNER
Shenzhen Well.D Medical Electronics Co., Ltd., CN
IYO
Dec 23, 2009K092837OTI-SCAN 3000
Opko Instrumentation, Inc.
IYO
Nov 20, 2009K093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYO
Nov 13, 2009K092619ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER
Civco
IYO
Oct 9, 2009K092182VOYAGER COMPACT IMAGING SYSTEM
Ardent Sound, Inc.
IYO
Sep 18, 2009K090773CFI ULTRASOUND PROBE DRAPE
Contour Fabricators, Inc.
IYO
Aug 21, 2009K092140GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND
Ge Medical Systems Israel, Ultrasound, Ltd.
IYO
Aug 12, 2009K083728INVISION SYSTEM
Inneroptic Technology, Inc.
IYO
Jun 18, 2009K091518CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
Mcube Technology Co., Ltd.
IYO
May 26, 2009K091374GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
Ge Medical Systems China Co., Ltd., CN
IYO
May 7, 2009K090505SPEQ ULTRASOUND SYSTEM
Signostics Pty, Ltd.
IYO
Apr 30, 2009K090059IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
Saset (Chengdu), Inc., CN
IYO
Mar 13, 2009K090214VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
Verathon Incorporated
IYO
Jan 9, 2009K083061ELLEX INNOVATIVE IMAGING EYE CUBED V4
Ellex, Inc.
IYO
Dec 22, 2008K081148SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYO
Dec 1, 2008K082456VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
Verathon Incorporated
IYO
Oct 14, 2008K082543SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
Sonocine, Inc.
IYO
Oct 8, 2008K082229S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
Volcano Corporation
IYO
Aug 15, 2008K082185GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2
Ge Medical Systems Ultrasound and Primary Care Dia
IYO
Aug 7, 2008K080930MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
U-System, Inc.
IYO
Jul 16, 2008K081873EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE
Shenzhen Emperor Electronic Technology Co. , Ltd., CN
IYO
Jul 9, 2008K081781NUWAV
Laborie Medical Technologies, Corp.
IYO
Jun 24, 2008K080223ZURA TEE SYSTEM
Imacor, LLC
IYO
Jun 4, 2008K081121MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYO
May 23, 2008K081154ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
B-K Medical Aps, DK
IYO
May 16, 2008K081110SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
Shantou Institute of Ultrasonic Instuments
IYO
Feb 14, 2008K080234TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
Teratech Corp.
IYO
Jan 23, 2008K080049VASCUVIEW ULTRASOUND SYSTEM
Escalon Medical Corp.
IYO
Dec 19, 2007K073196MASTER-VU
Sonomed, Inc.
IYO
Dec 18, 2007K072676ACUSON X300 ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYO
Oct 17, 2007K072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
General Electric Co.
IYO
Sep 26, 2007K072517ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
Boston Scientific Corp
IYO
Aug 24, 2007K072210CHISON, MODEL 8300
Chison Medical Imaging Co., Ltd., CN
IYO
Aug 3, 2007K071996MYLAB30, MODEL 7300
Esaote, S.p.A.
IYO

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