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Radiology

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

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RecordFirmDate
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 (K073107)Nucletron Corporation2007-12-07
ORTHOGON (K073271)Agfa Healthcare Corporation2007-12-05
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE (K073236)Neocoil2007-11-30
MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (K072780)Ralco S.R.L.2007-11-26
IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K (K072867)Imix Adr Finland OY2007-11-21
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL (K073181)Neocoil, LLC2007-11-21
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X (K073081)Toshiba America Medical Systems, In.C2007-11-21
MRI SYSTEM, MODEL MAGFINDER II / AI 3200 (K072850)Advanced Imaging Laboratory2007-11-21
INTEGRADWEB PACS SYSTEM (K072986)GE Healthcare2007-11-20
FMRI HARDWARE SYSTEM (K073099)Nordicneurolab2007-11-20
GE ECHOPAC (K072952)General Electric Co.2007-11-16
DRAD-3000E, RADREX-I (K073165)Toshiba America Medical Systems, In.C2007-11-16
COLLIMARE COLLIMATOR FAMILY (K073124)Collimare, LLC2007-11-16
LBS-63-16 BREAST ARRAY COIL (K072873)Invivo2007-11-16
INTERSTITIAL NEEDLES (K073133)Varian Medical Systems, Inc.2007-11-16
LBS-127-16 BREAST ARRAY COIL (K072874)Invivo2007-11-16
RAD VISION, MODELS E AND EU (K072659)Almana Medical Imaging2007-11-15
CHOY COMPRESSION FRAME (K070968)Choy Medical Technologies, Inc.2007-11-15
SATURN 9000-550 (K072984)New Medical Co., Ltd.2007-11-14
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 (K073056)Vieworks Co., Ltd.2007-11-13
SATURN 9000-750 (K072983)New Medical Co., Ltd.2007-11-13
ACUSON S2000 ULTRASOUND SYSTEM (K072786)Siemens Medical Solutions USA, Inc.2007-11-13
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM (K071760)Varian Medical Systems, Inc.2007-11-09
TRILOGY SYSTEM WITH RAPIDARC (K072916)Varian Medical Systems, Inc.2007-11-09
SPY FLUORESCENT IMAGING SYSTEM (K071619)Novadaq Technologies, Inc.2007-11-09
CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET (K072960)Cdp, Ltd.2007-11-08
MEDSTREAMING MEDICAL OFFICE SOFTWARE (K072972)Medstreaming, LLC2007-11-06
MULTI-SPECT (K073021)Eagle Heart Imaging, LLC2007-11-06
TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M (K072532)Dooyang Systems, Inc.2007-11-02
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS (K072998)Ge Medical Systems, LLC2007-11-01
CSNP-001A NEURO PACKAGE (K072693)Toshiba America Medical Systems, In.C2007-11-01
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL (K072909)Siemens AG Medical Solutions2007-10-31
SPEEDER 1.5T WRIST ARRAY COIL (K072935)Quality Electrodynamics2007-10-31
SYMBIA-E, MODEL 10275879 (K072567)Siemens Medical Solutions USA, Inc.2007-10-30
MC 3003G-32R HEAD COIL (K072931)Mr Instruments, Inc.2007-10-30
FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 (K072557)Faxitron X-Ray Corp.2007-10-30
MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 (K072918)Toshibamedical Systems Corporation2007-10-29
EXACTRAC 5.5 (K072506)Brainlab AG2007-10-26
TRACKPORT (K072529)Direx Systems Corp.2007-10-26
BEMITT, MODEL 0001 (K071787)Dja Distributors, LLC2007-10-26
DRYSTAR AXYS, MODEL EYZ4E (K072680)Agfa Healthcare Corporation2007-10-25
CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM (K072191)Gvi Technology Partners2007-10-25
HEXAPOD EVO RT COUCH TOP (K072898)Medical Intelligence Medizintechnik GmbH2007-10-25
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM (K072826)Toshiba America Medical Systems, In.C2007-10-24
ALPHARD CONE BEAM CT, MODEL X178 (K072574)Takara Belmont Corp.2007-10-18
EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM (K072046)Brainlab AG2007-10-17
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND (K072797)General Electric Co.2007-10-17
SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM (K072365)Siemens Medical Solutions USA, Inc., Ultrasound DI2007-10-17
NEUVIZ SPIRAL CT SCANNER SYSTEM (K072841)Neusoft Medical Systems Co., Ltd.2007-10-16
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS (K072454)Integra Radionics, Inc.2007-10-16
BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B (K070195)Broadsound Corporation2007-10-15
CARDIOP-B SYSTEM, VERSION 2.1 (K072591)Paieon, Inc.2007-10-10
MAGNETOM VERIO (K072237)Siemens Medical Solutions USA, Inc.2007-10-10
CSCS-001A CALCIUM SCORING PACKAGE (K072737)Toshiba America Medical Systems, In.C2007-10-05
SUNIRAY 5.2 (K072665)Orangedental GmbH & Co. KG2007-10-03
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM (K072606)Toshiba America Medical Systems, In.C2007-10-02
MONACO RTP SYSTEM (K071938)Computerized Medical Systems, Inc.2007-10-01
GATECT-RT (K072171)Vision RT Limited2007-10-01
MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM (K072468)Spectrum Dynamics , Ltd.2007-10-01
MIM 4.1 (SEASTAR) (K071964)Mimvista Corp.2007-09-26
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 (K072517)Boston Scientific Corp2007-09-26
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 (K072296)Theragenics Corp.2007-09-26
SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM (K072541)Senorx, Inc.2007-09-25
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM (K072392)Siemens Medical Solutions USA, Inc.2007-09-25
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K072504)Accuray Incorporated2007-09-21
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K072279)Hitachi Medical Systems America, Inc.2007-09-21
EMBRACE GEL (K072515)Orison Corporation2007-09-20
EOS (K071546)Biospace Med2007-09-18
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT (K072439)Ge Medical Systems Ultrasound and Primary Care Dia2007-09-14
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (K072445)Nucletron Corp.2007-09-14
SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS (K072090)Siemens Medical Solutions USA, Inc., Ultrasound DI2007-09-14
FIDUCIAL MARKERS (K071614)Civco2007-09-11
COR ANALYZER II, MODEL V1.7 (K072242)Rcadia Medical Imaging , Ltd.2007-09-11
SPY FLUORESCENT IMAGING SYSTEM (K072222)Novadaq Technologies, Inc.2007-09-07
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM (K072164)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-09-05
1.5T MRGFUS PELVIC COIL (K071966)Insightec-Txsonics, Inc.2007-09-05
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP (K071299)Digital Healthcare, Ltd.2007-08-31
OASIS RELEASE 1.0 (K071584)Segami Corporation2007-08-31
DAR-9400F (K072006)Shimadzu Corp.2007-08-31
ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM (K072285)Aloka Co., Ltd.2007-08-30
MODIFICATION TO GE LOGIQ A3 (K072075)General Electric Co.2007-08-29
ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM (K072266)Siemens Medical Solutions USA, Inc.2007-08-29
VISAGE PACS/CS, RELEASE VERSION 5.0 (K072205)Mercury Computer Systems, Inc.2007-08-29
MHI-TM2000 LINEAR ACCELERATOR SYSTEM (K072047)Mitsubishi Heavy Industries, Ltd.2007-08-29
FIRSTVIEW (K071492)Riverain Medical Group,Llc2007-08-28
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM (K071806)Hitachi Medical Systems America, Inc.2007-08-28
CHISON, MODEL 8300 (K072210)Chison Medical Imaging Co., Ltd.2007-08-24
AXIOM LUMINOS DRF (K062623)Siemens Medical Solutions USA, Inc.2007-08-22
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K071531)Accuray Incorporated2007-08-22
GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND (K071985)General Electric Co.2007-08-17
XEBRA DICOM IMAGE BROWSER (K071894)Hx Technologies, Inc.2007-08-16
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM (K071308)Neusoft Medical Systems Co., Ltd.2007-08-16
HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) (K071992)Varian Medical Systems2007-08-15
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) (K071682)Alara, Inc.2007-08-15
MAGNETOM ESSENZA (K071925)Siemens Medical Solutions USA, Inc.2007-08-14
1.3M MONOCHROME LCD MONITOR MDL1908A (K072066)Totoku Electric Co., Ltd.2007-08-14
IGUIDE SYSTEM (K072079)Medical Intelligence Medizintechnik-GmbH-An Elekta2007-08-14
20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2) (K072065)Totoku Electric Co., Ltd.2007-08-14
CODIAGNOSTIX (R) 5.72 (K071636)Ivs Solutions AG2007-08-09
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K071873)Varian Medical Systems, Inc.2007-08-09
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