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Radiology

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

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RecordFirmDate
XGEO GF50 (K140326)Samsung Electronics Co., Ltd.2014-05-29
CLEARVIEWHD (K140139)Clearview Diagnostics, Inc.2014-05-28
XGEO GU60A (K140332)Samsung Electronics Co., Ltd.2014-05-28
XGEO GC80 (K140334)Samsung Electronics Co., Ltd.2014-05-28
MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO) (K132684)Medecom Sarl2014-05-23
APLIO ARTIDA, V3.2 (K140729)Toshiba America Medical Systems, In.C2014-05-23
VIVID T8/VIVID T8 PRO (K141067)GE Healthcare2014-05-23
MAXIO (K132108)Perfint Healthcare Pvt, Ltd.2014-05-19
VSCAN WITH DUAL PROBE (K140693)Ge Medical Sysyems Ultrasound & Primary Care Diagn2014-05-16
XGEO GR40CW (K140235)Samsung Electronics Co., Ltd.2014-05-15
6VT-D ULTRASOUND TRANSDUCER (K141093)Ge Vingmed Ultrasound AS2014-05-15
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS (K133664)Ge Medical Systems Ultrasound & Primary Care Diagn2014-05-15
RAY STATION (K140187)Raysearch Laboratories AB2014-05-15
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM (K133620)Imaging Sciences International2014-05-14
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM (K141010)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2014-05-14
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A (K140060)Rayence Co., Ltd.2014-05-13
DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A (K140056)Rayence Co., Ltd.2014-05-13
VITREA IMAGE DENOISING SOFTWARE (K140395)Vital Images, Inc.2014-05-13
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL (K140606)Resonance Innovations, LLC2014-05-12
LEKSELL GAMMA KNIFE PERFEXION (K133565)Elekta Instrument AB2014-05-09
16 CH MULTIPURPOSE COIL VARIETY (K140252)Noras Rontgen-Und Medizintechnik GmbH2014-05-08
HERMES MEDICAL IMAGING SUITE V5.4 (K140269)Hermes Medical Solutions AB2014-05-08
SCINTILLATION GAMMA CAMERA (K140206)Ddd-Diagnostic A/S2014-05-08
HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM (K140899)Halo Medical Technologies, LLC2014-05-05
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS (K140856)C.R. Bard, Inc.2014-05-02
OEC 9800 PLUS (K132027)Ge Oec Medical Systems, Inc.2014-05-01
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS (K140959)Siemens Medical Solutions USA, Inc.2014-04-30
SOMATOM PERSPECTIVE (K133590)Siemens Medical Solutions USA, Inc.2014-04-30
ARTIS ONE (K133580)Siemens Medical Solutions USA, Inc.2014-04-28
MYLABSSOGNO (K140677)Esaote, S.p.A.2014-04-25
TERASON USMART3400 ULTRASOUND SYSTEM (K140834)Teratech Corp.2014-04-25
PHILIPS ELEVA WORKSPOT (K140771)Philips Medical Systems Dmc GmbH2014-04-25
DISCOVERY IGS 740 (K133278)GE Medical Systems SCS2014-04-24
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC (K140445)Imaging Sciences International, LLC2014-04-23
HEPATIC VCAR (K133649)GE Medical Systems SCS2014-04-22
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 (K133761)Toshibamedical Systems Corporation2014-04-22
GENTLECARE AR APPLICATOR (K133922)Gc Medtech, LLC2014-04-18
Q-STATION (K140808)Philips Ultrasound, Inc.2014-04-17
SOMATOM FORCE (K133589)Siemens Medical Solutions USA, Inc.2014-04-17
PVMED DDR 2430T (K133524)Portavision Medical, LLC2014-04-16
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (K140639)Hitachi Aloka Medical, Ltd.2014-04-16
6200 / 6250 ULTRASOUND SYSTEM (K133905)Esaote, S.p.A.2014-04-15
AZE PHOENIX SOFTWARE (K133521)Aze, Ltd.2014-04-11
REVOLUTION CT (K133705)Ge Medical Systems, LLC2014-04-11
DECLIPSESPECT LAPAROSCOPY (K133781)Surgiceye GmbH2014-04-11
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G (K140646)Rayence Co., Ltd.2014-04-11
MULTIX SELECT DR (K132934)Siemens Medi Cal Solutions, Inc.2014-04-10
SYNGO DUAL ENERGY SOFTWARE PACKAGE (K132902)Siemens Medical Solutions USA, Inc.2014-04-07
NORDICBRAINEX (K133910)Nordicneurolab2014-04-04
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT (K132381)Clearmri Solutions, Inc.2014-04-04
8MP COLOR LCD MONITOR, RADIFORCE RX850 (K140702)Eizo Corporation2014-04-04
ARIA RADIATION THERAPY MANAGEMENT (K133572)Varian Medical Systems, Inc.2014-04-04
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET (K130757)Spencer Fillmore2014-04-03
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE (K133914)Medcom GmbH2014-04-03
VIZION ULTRA (K133139)Viztek, LLC2014-04-03
TABLET VIEWER SOFTWARE FOR IMAGE SUITE (K140271)Carestream Health, Inc.2014-04-01
VUPAD (K140199)Sonomed, Inc.2014-04-01
AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR (K122298)Ajex Meditech., Ltd.2014-03-28
CORONIS 5MP (K133984)Barco N.V.2014-03-28
X-RAY TV SYSTEM SONIAL VISION G4 (K131075)Shimadzu Corp.2014-03-28
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER (K134016)Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014-03-28
ORTHOSCAN FD MINI C-ARM (K133174)Orthoscan, Inc.2014-03-28
PDE-NEO (K133719)Hamamatsu Photonics K.K.2014-03-27
OP300 (K133544)Palodex Group OY2014-03-26
RESOLUTIONMD MOBILE (K133508)Calgary Scientific, Inc.2014-03-26
CAAS WORKSTATION (K133993)Pie Medical Imaging2014-03-25
ASIR-V (K133640)Ge Medical Systems, LLC2014-03-25
ASPIRE CRISTALLE (K133972)Fujifilm Medical Systems U.S.A, Inc.2014-03-25
NIO COLOR 2MP (K133663)Barco N.V.2014-03-25
TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM (K140524)Teratech Corp.2014-03-21
NOVA FA DR SYSTEM (K133782)Sedecal., Sa.2014-03-21
DISCOVERY PET/CT 710 (K133657)Ge Medical Systems, LLC2014-03-21
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE (K140253)Siemens Medical Solutions USA, Inc.2014-03-20
FORESEE (4C) IMAGING SYSTEM (K133209)Diagnostic Photonics, Inc.2014-03-17
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (K132944)Ge Hungary Kft2014-03-14
RADIANCE 330 PROTON THERAPY SYSTEM (K134052)Protom International, Inc.2014-03-14
CS 8100 3D (K133406)Trophy2014-03-14
VOLCANO IFR MODALITY (K133323)Volcano Corporation2014-03-14
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING (K133227)Varian Medical Systems, Inc.2014-03-14
BONE SUPPRESSION SOFTWARE (K133442)Carestream Health, Inc.2014-03-11
ACCURO 3000 ULTRASOUND SCANNER (K132736)Rivanna Medical, LLC2014-03-11
CIOS ALPHA (K132094)Siemens Medi Cal Solutions, Inc.2014-03-11
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL (K133401)Siemens Medical Solutions USA, Inc.2014-03-11
ISYS 1 (U.S),ACCESSORY, NON-STERILE (K131433)Isys Medizintechnik GmbH2014-03-11
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS (K140291)Volcano Corporation2014-03-07
TABLE (K140093)Anatomage, Inc.2014-03-07
IMPAX VOLUME VIEWING 3.0 (K133135)Agfa Healthcare N.V.2014-03-07
VENTRIPOINT MEDICAL SYSTEM (K140153)Ventripoint, Inc.2014-03-06
MODEL-BASED RSA SOFTWARE (K133966)Halifax Biomedical, Inc.2014-03-06
ZEDVIEW (K133022)Lexi Co., Ltd.2014-03-06
ALLURA XPER FD; OR TABLE (K133292)Philips Medical Systems Nederland B.V.2014-03-05
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT (K132908)Medtec, Inc.2014-03-04
SONIC WINDOW (K140126)Analogic Corporation2014-03-04
HEARTSCAN SOFTWARE (K133937)Morpheus Imaging, Inc.2014-03-03
SKINTELL (K132800)Agfa Healthcare N.V.2014-03-03
ADVANCED VIEWER (K132763)Brainlab AG2014-02-28
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM (K131896)Suzhou Anke Medical System Co., Ltd.2014-02-28
BIOMARC FIDUCIAL MARKER (K132064)Carbon Medical Technologies, Inc.2014-02-28
SCENIUM (K133654)Siemens Medical Solutions USA, Inc.2014-02-28
THE DOME S6C (K133609)Nds Surgical Imaging2014-02-28
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