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IYO

894 FDA 510(k) clearances · Product code

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RecordFirmDate
Accuro (K171594)Rivanna Medical, LLC2017-10-20
BR-FHUS Navigation 1.0 (K171309)Taihao Medical, Inc.2017-09-29
BladderScan Prime PLUS System (K172356)Verathon Incorporated2017-09-15
FibroScan 430 Mini+ (K172142)Echosens2017-09-13
Scanmate Flex (K171301)Dgh Technology, Inc.2017-07-31
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System (K171824)Edan Instruments, Inc.2017-07-18
Acuson SC2000 Diagnostic Ultrasound System (K171766)Siemens Medi Cal Solutions, Inc.2017-07-12
CUBEScan™ BioCon-900 (Bladder Volume Measurement System) (K171591)Mcube Technology Co., Ltd.2017-06-22
MELODY, Remote Control System for Ultrasound Probe (K161354)Adecho Tech2017-06-12
QT Ultrasound Breast Scanner-1 (K162372)Qt Ultrasound, LLC2017-06-06
FFR V2.5 (K170133)Philips Volcano2017-05-26
CORE M2 Vascular System (K170385)Volcano Corporation2017-04-06
ExactVu High Resolution Micro-Ultrasound System (K162972)Exact Imaging2016-12-02
MicrUs (K161968)Telemed2016-11-03
Sonic Window (K161342)Analogic Corporation2016-06-15
Acclarix AX8 Diagnostic Ultrasound System (K161300)Edan Instruments, Inc.2016-05-31
Enovare Ultrasound System (K153620)Oreon Technologies, Inc.2016-05-05
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound (K160792)The Prometheus Group2016-04-15
Bladder Scanner (K153581)Caresono Technology Co., Ltd.2016-04-08
SpeqT (K160420)Signostics Limited2016-03-21
FibroScan 530 Compact (K160524)Echosens2016-03-18
ArcScan Insight 100 (K153416)Arcscan, Inc.2016-02-02
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz (K153369)Volcano Corporation2015-12-22
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (K152554)C.R. Bard, Inc.2015-12-14
4Sight (K152573)Accutome, Inc.2015-11-25
BladderScan Prime System (K153101)Verathon Incorporated2015-11-19
MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318)MEDA Co., Ltd.2015-11-17
iLab Ultrasound Imaging System (K152316)Boston Scientific2015-09-18
SONON Ultrasound Imaging System (Model: SONON 300C) (K151339)Healcerion Co., Ltd.2015-09-10
FibroScan (K150239)Echosens2015-09-01
Hi-Light Diagnostic Ultrasound Systems (K151709)Qingdao Hisense Medical Equipment Co., Ltd.2015-07-17
Ultrasound System SONIMAGE HS1 (K151060)Konica Minolta, Inc.2015-06-05
FibroScan (K150949)Echosens2015-06-03
Touch Ultrasound (K150342)Carestream Health, Inc.2015-05-08
Acclarix Diagnostic Ultrasound System (K150999)Edan Instruments, Inc.2015-05-06
UltraVision 2 Diagnostic Ultrasound System (K150580)Winprobe Corporation2015-04-07
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System (K150529)C.R. Bard, Inc.2015-03-30
Volcano iFR Modality, iFR Scout feature (K150441)Volcano Corporation2015-03-20
Volcano iFR Harvest Software (Offline) (K143122)Volcano Corporation2015-02-20
omni TRAX Active Patient Tracker (K143396)Civco Medical Instruments CO Inc Dba Civco Medical Solutions2015-01-23
SignosRT Bladder Ultrasound System (K143493)Signostics, Ltd.2015-01-14
BBS REVOLUTION (K142329)Dbmedx, Inc.2014-12-15
SoftVue (K142517)Delphinus Medical Technologies, Inc.2014-10-31
Site-Rite 6 Ultrasound System with Pinpoint GT Technology (K142443)C.R. Bard, Inc.2014-10-30
IMACOR ZURA EVO IMAGING SYSTEM (K142054)Imacor, Inc.2014-09-29
CLEAR GUIDE ONE (K141806)Clear Guide Medical2014-09-19
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems (K142395)Siemens Medical Solutions USA, Inc.2014-09-09
ULTRASOUND SCANNER SYSTEM BK2300 (K140428)B-K Medical Aps2014-05-30
HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM (K140899)Halo Medical Technologies, LLC2014-05-05
VUPAD (K140199)Sonomed, Inc.2014-04-01
VOLCANO IFR MODALITY (K133323)Volcano Corporation2014-03-14
ACCURO 3000 ULTRASOUND SCANNER (K132736)Rivanna Medical, LLC2014-03-11
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS (K140291)Volcano Corporation2014-03-07
SONIC WINDOW (K140126)Analogic Corporation2014-03-04
ULTRASOUND SCANNER PRO FOCUS 2202 (K132346)B-K Medical Aps2014-01-10
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE (K133641)Volcano Corporation2013-12-20
SOFTVUE (K123209)Delphinus Medical Technologies, Inc.2013-12-19
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION (K133142)Volcano Corporation2013-11-15
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K132654)Siemens Medical Solutions USA, Inc. Ultrasound Gro2013-09-26
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K131830)Edan Instruments, Inc.2013-09-17
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM (K132228)Samsung Medison Co., Ltd.2013-08-20
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM (K131690)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-07-24
PADSCAN HD SERIES BLADDER SCANNER (K131227)Carenoso Technology Co., Ltd.2013-07-12
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION (K131489)Tractus Corporation2013-06-25
ISR'OBOT MONA LISA (K130944)Biobot Surgical Pte., Ltd.2013-06-07
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER (K121243)MEDA Co., Ltd.2013-05-03
FIBROSCAN (K123806)Echosens2013-04-05
PALM BLADDER SCANNER (K130229)Mianyang Meike Electronic Equipment Co., Ltd.2013-03-20
ILAB ULTRASOUND IMAGING SYSTEM (K130243)Boston Scientific Corp2013-03-01
A-SCAN PLUS CONNECT (K123349)Accutome, Inc.2013-01-29
ILAB ULTRASOUND IMAGING SYSTEM (K123535)Boston Scientific Corp2013-01-15
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM (K123898)Volcano Corporation2013-01-14
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM (K123616)Sonoscape Company Limited2012-12-21
DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM (K123185)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-11-02
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 (K122574)Edan Instruments, Inc.2012-10-12
VITASCAN LT SCANMASTER (K121689)Vitacon Medical, Inc.2012-09-19
AIM (K121479)Inneroptic Technology, Inc.2012-09-13
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM (K121422)Toshiba Medical Systems Coporation, Japan2012-08-16
E-CUBE 15 (K121888)Alpinion Medical Systems Co., Ltd.2012-07-26
SONIXGPS NEEDLE SENSOR (K111818)Ultrasonix Medical Corporation2012-06-13
VIEWFLEX XTRA ICE CATHETER (K121381)St Jude Medical2012-06-07
SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE (K120882)Bard Access Systems, Inc.2012-05-30
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K120201)Ge Vingmed Ultrasound AS2012-04-19
BLADDER SCANNER (K113304)MEDA Co., Ltd.2012-03-23
CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE (K112539)Leiker Regulatory & Quality Consulting2012-01-30
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM (K113486)Volcano Corporation2012-01-27
DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K113632)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2012-01-25
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT (K113680)Soma Access Systems, LLC2011-12-29
DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K113153)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2011-11-28
SONOSITE EDGE ULTRASOUND SYSTEM (K113156)Sonosite,Inc.2011-11-15
DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K112022)Advanced Instrumentations, Inc.2011-09-22
ISROBOT MONA LISA (K111347)Biobot Surgical Pte., Ltd.2011-08-12
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM (K111706)Volcano Corporation2011-07-15
DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K111435)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2011-07-08
MYLABGOLD (K110688)Esaote2011-06-02
ECHO BLASTER (K102253)Telemed2011-03-14
AIDA DIAGNOSTIC ULTRASOUND SYSTEM (K103148)Panasonic Healthcare Co., Ltd.2011-03-11
MOBIUS ULTRASOUND IMAGING SYSTEM (K102153)Mobisante, Inc.2011-01-20
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND (K103608)Ellex, Inc.2010-12-27
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM (K102027)Quantel Medical S.A.2010-12-22
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