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Radiology

14,649 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K130119)Sonoscape Company Limited2013-04-12
SPINE COIL (K123708)Usa Paramed Medical Systems, Inc.2013-04-10
SYNAPSE 3D CARDIAC TOOLS (K130383)Fujifilm Medical System U.S.A., Inc.2013-04-09
FIBROSCAN (K123806)Echosens2013-04-05
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM (K130308)Hitachi Aloka Medical, Ltd.2013-04-05
INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 (K130069)GE Healthcare2013-04-05
AGILITY (K123808)Elekta , Ltd.2013-04-04
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS (K123263)Eckert & Ziegler Bebig GmbH2013-04-04
SPEQRT ULTRASOUND SYSTEM (K130659)Signostics Pty, Ltd.2013-04-03
INTUITION (K121916)Terarecon,Inc.2013-04-02
SYNGO.CT NEURO PERFUSION (K123541)Siemens Medical Systems, Inc.2013-04-02
EXCELSIOR (K130453)Eyekor, LLC2013-04-02
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM (K123509)Hitachi Medical Systems America, Inc.2013-03-29
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 (K130336)Eizo Nanao Corporation2013-03-28
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM (K123272)Neocoil, LLC2013-03-28
NOBELCLINICIAN (K123976)Nobel Biocare AB2013-03-26
SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K130173)FUJIFILM Sonosite, Inc.2013-03-25
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K130754)Siemens Medi Cal Solutions, Inc.2013-03-25
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM (K130619)Siemens Medical Solutions USA, Inc.2013-03-21
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 (K121772)Philips Medical Systems Nederland B.V.2013-03-21
MIRADA RTX (K130393)Mirada Medical, Ltd.2013-03-20
SUITEHEART (K130228)Neosoft, LLC2013-03-20
PALM BLADDER SCANNER (K130229)Mianyang Meike Electronic Equipment Co., Ltd.2013-03-20
GALILEOS FAMILY (K123070)Sirona Dental Systems GmbH2013-03-15
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 (K123186)Calgary Scientific, Inc.2013-03-14
ESOPHAGUS BOUGIE SET (K130251)Varian Medical Systems, Inc.2013-03-13
OPTIMA MR450W (K123522)Ge Healthcare (Ge Medical Systems, LLC)2013-03-13
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA (K123345)Rayence Co., Ltd.2013-03-12
RAYSCAN A-EXPERT 3D (K122981)Ray Co., Ltd.2013-03-12
SYNGO, CT BONE READING (K123584)Siemens Medical Solutions USA, Inc.2013-03-12
STEREOS WORKSTATION (K130395)Eos Imaging, Inc.2013-03-11
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE (K123815)Varian Medical Systems, Inc.2013-03-11
DX-D IMAGING PACKAGE (K122736)Agfa Healthcare N.V.2013-03-11
CALLISTO EYE (K123464)Carl Zeiss Meditec, AG2013-03-05
CURA COLLIMATOR (K123893)Cura Medical Technologies, LLC2013-03-04
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV (K123812)Siemens Medical Solutions USA, Inc.2013-03-01
MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS (K123426)Orpheus Medical , Ltd.2013-03-01
MAGNETOM ESSENZA WITH SYNGO MR D14 (K130262)Siemens Medical Solutions USA, Inc.2013-03-01
ILAB ULTRASOUND IMAGING SYSTEM (K130243)Boston Scientific Corp2013-03-01
XOFT AXXENT CERVICAL APPLICATORS (K123442)Icad, Inc.2013-02-27
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM (K123529)Siemens Medical Solutions USA, Inc.2013-02-26
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (K123433)Cedars-Sinai Medical Center2013-02-26
ACHILLES (K123238)Ge Medical Systems China Co., Ltd.2013-02-25
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING (K122578)Vital Images, Inc.2013-02-25
MAMMOMAL INSPIRATION (K122286)Siemens Medical Solutions USA, Inc.2013-02-22
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL (K123681)Wipro GE Healthcare Private, Ltd.2013-02-22
EOS (K123740)Eos Imaging2013-02-22
ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 (K130058)Olympus Medical Systems Corp.2013-02-22
EMORY CARDIAC TOOLBOX 4.0 (K123646)Syntermed, Inc.2013-02-22
VERIFICATION CONSOLE (K124002)Varian Medical Systems2013-02-21
ARIX RAD ACQUISITION CONSOLE (K123650)Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.2013-02-20
MDU5 PLUS STERILE BAG (K123424)Boston Scientific Corp2013-02-20
COMMUNIFY PACS VIEWER (K120851)Communify Health, LLC2013-02-19
MAMMOWORKSTATION (K123575)Image Diagnost International GmbH2013-02-19
CPI RAD VISION (K122726)Communications & Power Industries Canada, Inc.2013-02-15
TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND (K122710)Shenzhen Delicate Electronics Co., Ltd.2013-02-15
DOSE TRACKING SYSTEM MODEL XIDF-DTS801 (K123097)Toshiba America Medical Systems, In.C2013-02-13
ULTRASOUND SCANNER FLEX FOCUS (K123254)B-K Medical Aps2013-02-13
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN (K123938)Siemens Medical Solutions USA, Inc.2013-02-12
4MP COLOR LCD MONITOR, RADIFORCE RX440 (K130070)Eizo Nanao Corporation2013-02-08
SURGERY REHEARSAL PLATFORM (K123023)Surgical Theater, LLC2013-02-08
DIAGNOSTIC ULTRASOUND SYSTEM (K123249)Edan Instruments, Inc.2013-02-08
OPTIMA CT520 (K123596)Ge Hangwei Medical Systems Co., Ltd.2013-02-08
CORONIS FUSION 6MP (K130103)Barco N.V.2013-02-08
M2 WRIST MRI SYSTEM (K120701)Aspect Imaging, Ltd.2013-02-07
SHEATHES STERILE ULTRASOUND GEL (K130041)Sheathing Technologies, Inc.2013-02-06
CAAS INTRAVASCULAR (K123970)Pie Medical Imaging BV2013-02-06
APLIO 500/400/300 V3.0 (K123992)Toshibamedical Systems Corporation2013-02-06
VIVIX-S WIRELESS (K122865)Vieworks Co., Ltd.2013-02-01
INVIVO DENTAL (K123519)Anatomage, Inc.2013-02-01
E-CUBE 15 (K123610)Alpinion Medical Systems Co., Ltd.2013-02-01
SYNGO, BREAST CARE (K123420)Siemens Medical Solutions USA, Inc.2013-02-01
PLANMED VERITY (K121418)Planmed OY2013-02-01
MICRODOSE SI (K123995)Philips Digital Mammography Sweden AB2013-02-01
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA (K122928)Rayence Co., Ltd.2013-01-30
ILUMIEN OPTIS (K123369)Lightlab Imaging, Inc.2013-01-30
TRACTUS TISSUEMAPPER REVIEWER APPLICATION (K123901)Tractus Corporation2013-01-29
BIOGRAPH MCT FAMILY (K123737)Siemens Medical Solutions USA, Inc.2013-01-29
IMAGEQUBE (K124048)Intuitive Imaging Informatics, LLC2013-01-29
GE ECHOPAC (K123894)Ge Vingmed Ultrasound AS2013-01-29
PROCEDURE REHEARSAL STUDIO (K123269)Simbionix , Ltd.2013-01-29
A-SCAN PLUS CONNECT (K123349)Accutome, Inc.2013-01-29
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY (K123873)Hologic, Inc.2013-01-29
DECLIPSESPECT VIEWER (K123917)Surgiceye GmbH2013-01-25
FERRISCAN R2-MRI ANALYSIS SYSTEM (DEN130012)Resonance Health Analysis Services Pty, Ltd.2013-01-23
SYNGO.VIA MI WORKFLOWS (K123577)Siemens Medical Solutions USA, Inc.2013-01-22
SYNAPSE 3D COLON ANALYSIS (K123566)Fujifilm Medical Systems U.S.A, Inc.2013-01-22
XGEO GC80 (K123098)Samsung Electronics Co., Ltd.2013-01-18
SYNGO.VIA (K123920)Siemens AG Medical Solutions2013-01-18
CARDIAC VX (K121762)Ge Medical Systems, LLC2013-01-18
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (K123828)Hitachi Aloka Medical, Ltd.2013-01-18
GENESIS (K122768)Dornier Medtech America, Inc.2013-01-18
BRIVO MR355, OPTIMA MR360 (K123417)Ge Hangwei Medical Systems Co., Ltd.2013-01-17
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 (K122951)Icad, Inc.2013-01-17
SYNGO DYNAMICS (K123922)Siemens Medical Solutions USA, Inc.2013-01-16
ILAB ULTRASOUND IMAGING SYSTEM (K123535)Boston Scientific Corp2013-01-15
INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) (K123788)Varian Medical Systems, Inc.2013-01-15
ERGO IMAGING SYSTEM (K123408)Digirad Corp.2013-01-15
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM (K123898)Volcano Corporation2013-01-14
IB CLINIC (K123302)Imaging Biometrics, LLC2013-01-11
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