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IYO

894 FDA 510(k) clearances · Product code

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RecordFirmDate
COMPACT TOUCH STS (K102198)Quantel Medical S.A.2010-11-05
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM (K102393)Ge Medical System Israel , Ltd.2010-11-05
M5 DIAGNOSTIC ULTRASOUND SYSTEM (K102991)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-10-22
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K101149)Ge Vingmed Ultrasound AS2010-10-13
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM (K101337)Sonoscape Company Limited2010-09-30
ECO SUPERGEL (K101429)Ceracarta Spa2010-09-15
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS (K093466)Hitachi Medical Systems America, Inc.2010-06-17
ULTRA DCI MODEL 5000 (K100363)Ultrasound Medical Devices, Inc.2010-05-21
COMPACT TOUCH (K094038)Quantel S.A.2010-04-22
MASTER-VU A-SCAN, MV4500 (K100252)Sonomed, Inc.2010-04-09
MODEL DGH 6000 SCANMATE A (K093371)Dgh Technology, Inc.2010-04-05
VESISCAN (K093485)Life-Tech, Inc.2010-03-16
DIGITAL ULTRASOUND SCANNER (K100079)Shenzhen Well.D Medical Electronics Co., Ltd.2010-03-01
OTI-SCAN 3000 (K092837)Opko Instrumentation, Inc.2009-12-23
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM (K093488)Aloka Co., Ltd.2009-11-20
ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER (K092619)Civco2009-11-13
VOYAGER COMPACT IMAGING SYSTEM (K092182)Ardent Sound, Inc.2009-10-09
CFI ULTRASOUND PROBE DRAPE (K090773)Contour Fabricators, Inc.2009-09-18
GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND (K092140)Ge Medical Systems Israel, Ultrasound, Ltd.2009-08-21
INVISION SYSTEM (K083728)Inneroptic Technology, Inc.2009-08-12
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM (K091518)Mcube Technology Co., Ltd.2009-06-18
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND (K091374)Ge Medical Systems China Co., Ltd.2009-05-26
SPEQ ULTRASOUND SYSTEM (K090505)Signostics Pty, Ltd.2009-05-07
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM (K090059)Saset (Chengdu), Inc.2009-04-30
VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND (K090214)Verathon Incorporated2009-03-13
ELLEX INNOVATIVE IMAGING EYE CUBED V4 (K083061)Ellex, Inc.2009-01-09
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER (K081148)Siemens Medical Solutions USA, Inc., Ultrasound DI2008-12-22
VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 (K082456)Verathon Incorporated2008-12-01
SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 (K082543)Sonocine, Inc.2008-10-14
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM (K082229)Volcano Corporation2008-10-08
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 (K082185)Ge Medical Systems Ultrasound and Primary Care Dia2008-08-15
MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS (K080930)U-System, Inc.2008-08-07
EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE (K081873)Shenzhen Emperor Electronic Technology Co. , Ltd.2008-07-16
NUWAV (K081781)Laborie Medical Technologies, Corp.2008-07-09
ZURA TEE SYSTEM (K080223)Imacor, LLC2008-06-24
MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM (K081121)Siemens Medical Solutions USA, Inc., Ultrasound DI2008-06-04
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 (K081154)B-K Medical Aps2008-05-23
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM (K081110)Shantou Institute of Ultrasonic Instuments2008-05-16
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO (K080234)Teratech Corp.2008-02-14
VASCUVIEW ULTRASOUND SYSTEM (K080049)Escalon Medical Corp.2008-01-23
MASTER-VU (K073196)Sonomed, Inc.2007-12-19
ACUSON X300 ULTRASOUND SYSTEM (K072676)Siemens Medical Solutions USA, Inc.2007-12-18
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND (K072797)General Electric Co.2007-10-17
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 (K072517)Boston Scientific Corp2007-09-26
CHISON, MODEL 8300 (K072210)Chison Medical Imaging Co., Ltd.2007-08-24
MYLAB30, MODEL 7300 (K071996)Esaote, S.p.A.2007-08-03
SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER (K071156)Sounmed, Inc.2007-07-03
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS (K071314)Siemens Medical Solutions USA, Inc.2007-05-22
SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 (K071204)C.R. Bard, Inc.2007-05-18
BLADDERSCAN BVI 9400 ULTRASOUND (K071217)Verathon Incorporated2007-05-17
SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM (K071134)Sonosite,Inc.2007-05-08
CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM (K070982)Shantou Institute of Ultrasonic Instuments2007-05-02
B-SCAN PLUS (K070943)Accutome Ultrasound, Inc.2007-04-19
INTERSON USB ULTRASOUND PROBE SYSTEM (K070907)Regulatory Management Services2007-04-17
POD B-SCAN (K070884)Starfish Product Engineering, Inc.2007-04-11
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K070526)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-03-23
ORISON EMBRACE SYSTEM (K070477)Orison Corporation2007-03-09
ULTRASOUND SCANNER PROFOCUS, MODEL 2202 (K070077)B-K Medical Aps2007-03-05
ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 (K063472)Meda , Ltd.2007-01-31
ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 (K063433)Meda , Ltd.2007-01-29
LONGPORT EPISCAN, MODEL-I-200 (K062571)Longport, Inc.2006-11-21
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM (K063085)Siemens Medical Solutions USA, Inc.2006-11-14
VOLCANO S51 FAMILY OF IMAGING SYSTEMS (K061215)Volcano Corporation2006-08-10
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM (K061755)Esaote Europe B.V.2006-08-07
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO (K061641)Shimadzu Medical Systems2006-07-14
GE VOLUSON E8 ULTRASOUND SYSTEM (K061682)General Electric Co.2006-07-12
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM (K060483)Volcano Corporation2006-06-23
CTS-7700 (K061083)Shantou Institute of Ultrasonic Instuments2006-06-06
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K061189)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-06-01
DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K060949)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-05-04
IVIEW (K053306)Ondemandsoft2006-04-19
VUMAX (K060626)Sonomed, Inc.2006-04-11
SEEKER/SPARK ULTRASOUND SYSTEM (K060800)Ardent Sound, Inc.2006-04-07
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 (K053346)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005-12-09
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 (K053325)Mediwatch, Ltd.2005-12-07
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV (K052348)Volcano Corporation2005-12-02
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS (K052355)U-Systems, Inc.2005-09-14
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 (K051920)Volcano Corporation2005-08-19
DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K052113)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005-08-09
AVISO OPHTHALMIC ULTRASOUND SYSTEM (K051851)Quantel Medical2005-08-03
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A (K051500)Toshiba America Medical Systems, In.C2005-06-17
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM (K051304)Science Surgical Corporation2005-06-03
ULTRASONIC BIO-MICROSCOPE, MODEL P60 (K050980)Paradigm Medical Industries, Inc.2005-05-26
PACHPEN PACHYMETER, MODEL 24-5100 (K050552)Accutome, Inc.2005-03-28
VOYAGER PERSONAL IMAGING DEVICE (K050551)Ardent Sound, Inc.2005-03-22
SONALIS, MODEL 2000 (K043189)3g Ultrasound, Inc.2005-02-09
CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE (K050167)Chison Medical Imaging Co., Ltd.2005-02-08
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K043563)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005-01-11
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS (K042620)Tetrad Corp.2004-12-23
PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 (K043287)Micromedical Devices, Inc.2004-12-10
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER (K043275)Olympus Medical Systems Corporation2004-12-09
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A (K043078)Toshiba America Medical Systems, In.C2004-11-17
SENSATOUCH (K042250)Aluna Management Co., Ltd.2004-11-12
VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM (K042188)Volcano Therapeutics, Inc.2004-11-10
ACCUPACH V (K042752)Accutome Ultrasound, Inc.2004-11-10
ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) (K042831)Reichert, Inc.2004-10-28
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS (K042833)Siemens Medical Solutions USA, Inc.2004-10-27
PHILIPS IU22 ULTRASOUND SYSTEM (K042540)Philips Ultrasound, Inc.2004-10-04
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM (K041639)Envisioneering, LLC2004-09-02
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND (K041947)Innovative Imaging, Inc.2004-08-16
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