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Radiology

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

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RecordFirmDate
OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 (K092899)Ningbo Xingaoyi Magnetism Co., Ltd.2009-11-10
DX-D IMAGING PACKAGE (K092669)Agfa Healthcare N.V.2009-11-06
CADSTREAM VERSION 5 (K092954)Confirma, Inc.2009-11-06
SHIMADZU COLLIMATOR R-30H (K090578)Shimadzu Corp.2009-11-06
CAPRI APPLICATOR (K092822)Vivaray, Inc.2009-11-03
INTEGRATED REGISTRATION (K093234)GE Medical Systems SCS2009-10-30
MITS DICOM GATEWAY AND IMAGE MANAGER (K092581)Mitsmed Medical Instrument Technology Co., Ltd.2009-10-30
DIRECT DIGITIZER, REGIUS MODEL 210 (K092717)Konica Minolta Medical & Graphic, Inc.2009-10-30
CYPHER DICOM PRINT SOLUTION (K092280)Virtual Imaging, Inc.2009-10-16
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM (K092691)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009-10-15
PATLOG 2.0 (K092939)Oncolog Medical QA AB2009-10-09
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL (K092747)Philips Medical Systems (Cleveland), Inc.2009-10-09
CAROTID COIL 5000004901 (K092962)Shanghai Chenguang Medical Technologies Co, Ltd.2009-10-09
VOYAGER COMPACT IMAGING SYSTEM (K092182)Ardent Sound, Inc.2009-10-09
APLIO MX SSA-780A, VERSION 1.0 (K092948)Toshiba America Medical Systems, In.C2009-10-09
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO (K090991)E-Woo Technology2009-10-09
MICROSELECTRON HDR V2, MODEL 105.999 (K092804)Nucletron Corp.2009-10-08
MODIFICATION TO FMRI HARDWARE SYSTEM (K092253)Nordicneurolab2009-10-08
PMD VIEWER (K092204)Spencer Technologies2009-10-08
IMAGEGRID RADIOLOGY VIEWER SYSTEM (K092949)Candelis, Inc.2009-10-08
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO (K091918)Genoray Co., Ltd.2009-10-07
STELLAR FIDUCIAL MARKER, MODEL GFMIA (K092041)Stellar Medical, LLC2009-10-02
MODEL SENTINELLA 102 (K092471)General Equipment For Medical Imaging, S.A.2009-10-02
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (K092058)Sonosite,Inc.2009-10-02
SHEATHESISO ULTRASOUND TRANSDUCER COVER (K091828)Sheathing Technologies, Inc.2009-09-28
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM (K092756)Ge Vingmed Ultrasound AS2009-09-28
PACSCAN PLUS, MODELS 300P AND 300AP (K092637)Sonomed, Inc.2009-09-24
XIO RTP SYSTEM (K092132)Computerized Medical Systems, Inc.2009-09-24
EXTEND FRAME SYSTEM, MODEL 1009633 (K092083)Elekta Instrument AB2009-09-22
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K092742)Neusoft Medical Systems Co., Ltd.2009-09-22
ABVS WORKPLACE (K092067)Siemens AG Medical Solutions2009-09-18
OMNIPRO INCLINE (K092018)Iba Dosimetry GmbH2009-09-18
VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 (K092653)Medcom GmbH2009-09-18
CFI ULTRASOUND PROBE DRAPE (K090773)Contour Fabricators, Inc.2009-09-18
160MLC OPTION (K092145)Siemens Medical Solutions USA, Inc.2009-09-18
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A (K090742)Samsung Mobile Display Co., Ltd.2009-09-18
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K091999)Accuray, Inc.2009-09-18
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) (K092134)Statrad, LLC2009-09-15
MODEL 1014 PC ELECTROMETER (K092019)Sun Nuclear Corp.2009-09-15
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA (K091117)Isoaid, LLC2009-09-15
NSM-S15 SYSTEM (K092237)Neusoft Medical Systems Co., Ltd.2009-09-09
INREACH SYSTEM, MODEL AAS00161-02 (K092365)Superdimension, Ltd.2009-09-04
IMRX (K091166)Imris, Inc.2009-09-02
CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL (K091877)Chison Medical Imaging Co., Ltd.2009-09-02
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 (K092458)Isoray Medical, Inc.2009-08-28
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 (K092285)Best Medical Canada , Ltd.2009-08-28
INSPIRA HD, MODEL: NL1000 (K090811)Neurologica Corporation2009-08-27
SYNGO.X (K092519)Siemens AG Medical Solutions2009-08-27
MAMMOSITE MULTI LUMEN (K092405)Hologic, Inc.2009-08-27
IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR (K092307)Imasight, Inc.2009-08-25
NORDICBRAINEX SOFTWARE, VERSION 1.0 (K092102)Nordicimaginglab AS2009-08-25
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ (K092004)GE Healthcare2009-08-25
GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND (K092140)Ge Medical Systems Israel, Ultrasound, Ltd.2009-08-21
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX (K091628)Protec GmbH & Co. KG2009-08-21
1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 (K091902)Invivo2009-08-21
CONTURA CAVITY MAINTENANCE CATHETER (K092323)Senorx, Inc.2009-08-19
MEDI-6000 MEDICAL IMAGE DIGITIZER (K091288)Microtek International, Inc.2009-08-14
HDR PROSTATE TEMPLATE AND ACCESSORIES (K091230)Photon Technologies Corporation2009-08-12
AIXPLORER ULTRASOUND SYSTEM (K091970)Supersonic Imagine2009-08-12
INVISION SYSTEM (K083728)Inneroptic Technology, Inc.2009-08-12
PROTEUS 235 PROTON THERAPY SYSTEM (K091629)Ion Beam Applications S.A.2009-08-11
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS (K092238)Agfa Healthcare N.V.2009-08-11
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 (K092136)Isoray Medical, Inc.2009-08-07
BEYONDIMAGE WORKSTATION (K092235)Neusoft Medical Systems Co., Ltd.2009-08-06
MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND (K092079)Ge Medical Systems Israel, Ultrasound, Ltd.2009-08-06
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (K091403)Oncology Tech, LLC2009-07-29
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 (K092179)Toshiba America Medical Systems, In.C2009-07-29
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM (K092159)Medison Co., Ltd.2009-07-28
PICA WHOLE BODY MRI SYSTEM (K091580)Time Medical Limited2009-07-24
MR-TOUCH OPTION (K083421)Ge Medical Systems, LLC2009-07-24
QXLINK (K092081)Vieworks Co., Ltd.2009-07-21
GOLD ANCHOR (K091645)Naslund Medical AB2009-07-21
BOLUS COMPENSATOR (K091911).Decimal, Inc.2009-07-21
DRX-EVOLUTION, MODEL VX3733-SYS (K091889)Carestream Health, Inc.2009-07-20
LEKSELL GAMMAPLAN (K090972)Elekta Instrument AB2009-07-20
PERFSCAPE (K091444)Olea Medical2009-07-20
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS (K091804)Philips Ultrasound, Inc.2009-07-17
OPTIMA MR450W (K091536)Ge Medical Systems, LLC2009-07-17
SYNGO VOLUME PERFUSION-CT BODY (K092013)Siemens AG Medical Solutions2009-07-17
BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM (K091558)Bioptics, Inc.2009-07-17
MONACO RTP SYSTEM, VMAT OPTION (K091179)Computerized Medical Systems, Inc.2009-07-16
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E (K090914)Xoft, Inc.2009-07-16
TIGRT TPS (K090893)Linatech, LLC2009-07-15
PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 (K090655)Source-Ray, Inc.2009-07-14
RALCO, MODEL R225 ACS (K091517)Ralco S.R.L.2009-07-14
CORONIS 5MP HD, MODEL MDMG 5121 (K091274)Barco N.V.2009-07-14
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K091941)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009-07-09
PACSMATE, MODEL MMD-4300C/MMD-4300CX (K091687)Iei Technology Corp.2009-07-07
PACS PLUS 5TH EDITION (K083658)Medical Standard Co., Ltd.2009-07-07
TIGRT MLC, TIGRT DMLC (K090802)Linatech, LLC2009-07-07
MAMMOSITE II RADIATION THERAPY SYSTEM (K091378)Hologic, Inc.2009-07-02
FLAATZ 500 (K091747)Drtech Corp.2009-07-01
IDR (K082450)Icrco, Inc.2009-06-30
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION (K090268)Shimadzu Corp.2009-06-30
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS (K091325)Cooper Surgical2009-06-29
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS (K091598)Nucletron Corp.2009-06-29
DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D (K083640)Choong Wae Medical Corp.2009-06-29
MR CARDIAC FUNCTION ANALYSIS (K091262)Ziosoft, Inc.2009-06-29
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 (K091658)GE Healthcare2009-06-29
MYRIAN 1.4 (K091001)Intrasense2009-06-29
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