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Radiology

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

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RecordFirmDate
IG4 IMAGE GUIDED SYSTEM (K060903)Veran Medical Technologies, Inc.2006-05-11
MUCHECK V7.0 (K061152)Oncology Data Systems, Inc.2006-05-10
ACCUREX (K061126)Cybermed, Inc.2006-05-09
AXIOM ARISTOS FX PLUS (K061054)Siemens Medical Solutions USA, Inc.2006-05-09
NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM (K060112)Nodecrest, LLC2006-05-05
OR HEAD COIL 1.5 T (K060758)Siemens Medical Solutions USA, Inc.2006-05-05
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS (K060671)Wfr/Aquaplast Corp.2006-05-04
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 (K060956)Esaote, S.p.A.2006-05-04
DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K060949)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-05-04
GE LOGIQ P5 AND A5 (K060993)General Electric Co.2006-05-03
SPY INTRAOPERATIVE IMAGING SYSTEM (K060867)Novadaq Technologies, Inc.2006-05-03
JETSTREAM WORKSPACE (K061029)Adac Laboratories2006-05-01
15-INCH (38CM) COLOR LCD MONITOR CDL1566A (K060961)Totoku Electric Co., Ltd.2006-05-01
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 (K060633)Siemens Medical Solutions USA, Inc.2006-05-01
SYNGO US WORKPLACE (K060992)Siemens Medical Solutions2006-04-28
PLANAR DOME EX LINE MODEL DOME E2C (K061018)Planar Systems, Inc.2006-04-28
MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310 (K060845)Eizo Nanao Corporation2006-04-25
IVA (MXA II SOFTWARE OPTION) (K060111)Hologic, Inc.2006-04-24
SURTRAK IMPLANTATION KIT (K060679)North American Scientific, Inc.2006-04-21
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 (K060947)Boston Scientific Corp2006-04-19
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE (K060636)C.R. Bard, Inc.2006-04-19
GE LIGHTSPEED XTRA CT SCANNER SYSTEM (K060052)Ge Medical Systems, LLC2006-04-19
MODIFICATION TO: HI-ART SYSTEM (K060912)Tomotherapy Incorporated2006-04-19
PROBEAT WITH MGCS (K060834)Hitachi , Ltd.2006-04-19
IVIEW (K053306)Ondemandsoft2006-04-19
ABARIS (K053610)Traxtal Technologies, Inc.2006-04-19
SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE (K052947)Source Production & Equipment Co., Inc.2006-04-19
CAAS MRV VERSION 3.0 (K060941)Pie Medical Imaging BV2006-04-19
MODEL EC9-4 TRANSDUCER (K060879)Siemens Medical Solutions USA, Inc.2006-04-19
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS (K060873)Sentinelle Medical, Inc.2006-04-14
IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K060695)Ion Beam Applications S.A.2006-04-11
VUMAX (K060626)Sonomed, Inc.2006-04-11
HDR 1000 PLUS WELL CHAMBER, MODEL 90008 (K060532)Standard Imaging, Inc.2006-04-11
STETHOFLUX (K060064)Odvi2006-04-10
SEEKER/SPARK ULTRASOUND SYSTEM (K060800)Ardent Sound, Inc.2006-04-07
SVIEW (K060840)Mri Cardiac Services, Incorporated2006-04-07
ROTATING GAMMA SYSTEM. GAMMA ART-6000 (K060314)American Radiosurgery, Inc.2006-04-06
MINXRAY, MODELS HFP24 AND HFP40 (K060566)Mikasa X-Ray Co., Ltd.2006-04-05
ADVANCE VESSEL ANALYSIS II (K060779)GE Healthcare2006-04-05
XPERCT (K060749)Philips Medical Systems North America Co.2006-04-04
DOSE VERIFICATION SYSTEM (K052118)Sicel Technologies, Inc.2006-04-03
SINMED POSITIONING DEVICES (K060737)Sinmed BV2006-03-31
KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 (K060550)Eastman Kodak Company2006-03-31
1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL (K060689)Resonance Innovations, LLC2006-03-31
MAXILIM (K052424)Medicim NV2006-03-31
GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX (K060542)General Electric Co.2006-03-31
INNOCURE IMRT FILTER (COMPENSATORS) (K052383)Innocure, LLC2006-03-29
O-ARM IMAGING SYSTEM (K060344)Breakaway Imaging, LLC2006-03-29
VOXAR 3D ENTERPRISE, MODEL 6.1 (K060505)Barcoview Mis Edinburgh2006-03-29
ACCU-SOURCE (K051753)Oncology Systems, Inc.2006-03-29
ACCESS BREAST COIL 4/SMS (K060547)Confirma, Inc.2006-03-29
CYCLONE, MODEL MAICAM 180 (K060486)Spectrica2006-03-23
M-VU VIEWER STATION (K060451)Vucomp, Inc.2006-03-22
BIOGRAPH 64 AND BIOGRAPH 40 (K060631)Siemens Medical Solutions USA, Inc.2006-03-17
VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE (K060267)Implant Logic Systems, Ltd.2006-03-17
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE (K060137)Eastman Kodak Company2006-03-16
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER (K060440)Codonics, Inc.2006-03-16
IQPACS (K060263)S.C. Info World S.R.L.2006-03-15
MEDRAD 3.0T ECOIL IMAGING SYSTEM (K060401)Medrad, Inc.2006-03-15
ONCOR EXPRESSION (K060226)Siemens Medical Solutions USA, Inc.2006-03-15
DIGITAL RADIOGRAPHY CXDI-50C (K060433)Canon, Inc.2006-03-10
CT PERFUSION 4 (K052839)GE Healthcare2006-03-10
PROGUIDE NEEDLE SET (K060349)Nucletron Corporation2006-03-10
MIGUE (K052212)Direx Systems Corp.2006-03-10
PROBEAT (K053280)Hitachi, Ltd., Power Systems Group2006-03-09
THERATRON EQUINOX, MODELS 80 CM AND 100 CM (K053485)Mds Nordion, Inc.2006-03-09
VITREA2 VERSION 3.8.1 (K060378)Vital Images, Inc.2006-03-09
MDXNET (K060035)Cybermdx, Inc.2006-03-09
AZE VIRTUALPLACE (K060453)Aze, Ltd.2006-03-09
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM (K052202)Siemens Medical Solutions USA, Inc.2006-03-07
AIM ACCURACY IN MARKING SYSTEM (K053463)Georgene Austria2006-03-07
CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF (K053039)Clinton Electronics Corp.2006-03-01
CURAY CUSTOM SEED ARRAY (K053595)Biolucent, Inc.2006-02-28
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 (K060259)Ge Medical Systems, LLC2006-02-22
DART-12 (K052705)Direx Systems Corp.2006-02-21
CXR16 (K053148)Hitachi Medical Systems America, Inc.2006-02-17
JIVE X SOFTWARE (K053183)Visus Technology Transfer GmbH2006-02-16
MEDIPORT (K060210)Maxant Technologies, Inc.2006-02-10
SIMPLANT DR. JAMES (K053592)Materialise NV2006-02-08
KODAK PACS (K060055)Eastman Kodak Company2006-02-07
BIOGRAPH 6 (K060060)Siemens Medical Solutions USA, Inc.2006-02-03
FRAMELESS RADIOSURGERY COMPONENTS (K053500)Brainlab AG2006-02-03
CEDARA I-RESPONSE CEDARA PET/CT (K053301)Cedara Software Corp.2006-02-03
PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR (K060136)Planar Systems, Inc.2006-01-31
MIE - GAMMA CAMERA SYSTEMS (K053086)Mie America, Inc.2006-01-27
ENCOMPASS.NET (K053455)Empiric Systems, LLC2006-01-25
ALTAIRE INTERVENTIONAL MR PACKAGE (K053309)Hitachi Medical Systems America, Inc.2006-01-24
IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K053641)Ion Beam Applications S.A.2006-01-24
PIONEER TC8080, COMPANION III (K053648)Viasys Neuro Care2006-01-24
ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM (K060087)Medison Co., Ltd.2006-01-24
AUTOQUANT PLUS (K060020)Adac Laboratories2006-01-20
EXCELART VANTAGE ZGV (K060003)Toshibamedical Systems Corporation2006-01-18
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION (K053634)Agfa Corporation2006-01-17
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION (K052423)Siemens Medi Cal Solutions, Inc.2006-01-13
ALOKA SD-3500 ULTRASOUND SYSTEM (K060059)Aloka Co., Ltd.2006-01-13
DELTA4 (K052920)Scandidos AB2006-01-12
CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 (K053062)Cardiarc , Ltd.2006-01-06
ALIGNRT (K052682)Vision RT Limited2006-01-06
MAYFIELD SCANMATE MOBILE CT SYSTEM (K053210)Schaerer Mayfield USA, Inc.2006-01-06
NDR+/DIVA-D (K053029)Nical Spa2006-01-06
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