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Radiology

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

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RecordFirmDate
LC POSITIONER (K981414)Fischer Imaging Corp.1998-07-16
CERVIX COIL LATEX SHEATH (K981406)Philips Medical Systems (Cleveland), Inc.1998-07-16
BIOPSY M (K982049)Sitco, Inc.1998-07-14
SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T (K974457)Hewlett-Packard Co.1998-07-14
FLUOROSPOT COMPACT (K982028)Siemens Medical Solutions USA, Inc.1998-07-14
XR-910 (K981466)Imaging Sciences Intl., Inc.1998-07-14
CAAS II LVA BIPLANE OPTION (K982203)Pie Medical Equipment B.V.1998-07-14
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE (K981475)Toshiba America Mri, Inc.1998-07-14
ARTOSCAN S (K981358)Biosound Esaote, Inc.1998-07-13
VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402 (K981352)Ge Medical Systems F.I. Haifa1998-07-13
RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM (K981346)Surgical Navigation Technologies, Inc.1998-07-10
SEQUENCER (K981313)Impac Medical Systems, Inc.1998-07-09
ADVANTAGE 3D XR (K974715)GE Medical Systems1998-07-06
NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 (K973363)Ml Strategies, Inc.1998-07-02
7200 ULTRASOUND IMAGING SYSTEM (K981293)Biosound Esaote, Inc.1998-06-30
HIGH IMPEDANCE CARDIAC GATING CABLE (K981190)GE Medical Systems1998-06-30
HAMMERSMITH ENDOCAVITARY COILS (K981410)Philips Medical Systems (Cleveland), Inc.1998-06-30
SYMPHONY 360 REMOTE CONTROL TABLE (K981227)Acoma Medical Imaging, Inc.1998-06-30
VANTAGE 3.0 INSYNCH (K981291)Adac Laboratories1998-06-29
RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM (K965223)Endosonics Corp.1998-06-29
PATHFINDER MOBILE C ARM (K981131)Acoma Medical Imaging, Inc.1998-06-26
RADIO-PLAST (K981115)Smith & Nephew, Inc.1998-06-25
KONICA DIRECT DIGITIZER REGIUS MODEL 330 (K980873)Konica Corp.1998-06-19
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE (K981470)Worldwide Medical Technologies, LLC1998-06-19
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (K981053)Eastman Kodak Company1998-06-18
MEDRAD NEUROVASCULAR COIL (K981094)Medrad, Inc.1998-06-18
PLATINUM READING, REVIEW & ANALYSIS WORKSTATION (K981217)GE Medical Systems1998-06-18
PHILIPS THORAVISION (K981657)Philips Medical Systems North America, Inc.1998-06-18
THE NETWORK SYSTEM (K980234)Medical Sni , Ltd.1998-06-17
COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO (K973864)Pausch Corp.1998-06-17
FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS (K980569)Norland Corp.1998-06-12
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER (K980289)Norland Corp.1998-06-12
VARIAN XIMATRON SCAN VISION CT (K981056)Varian Medical Systems, Inc.1998-06-12
MUCHECK MONITOR UNIT VALIDATION PROGRAM (K980904)Medical Dosimetry Services, Inc.1998-06-08
E.CAM LSO 311 PET/SPECT SYSTEM (K981027)Cti Pet Systems, Inc.1998-06-08
IIRAD DIRECTRAY OPERATOR CONSOLE (K980970)Sterling Diagnostic Imaging, Inc.1998-06-08
PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM (K974880)Perception, Inc.1998-06-08
3D-MSPECT (K980867)Adac Laboratories1998-06-04
EMORY CARDIAC TOOL BOX (K980914)Emory University1998-06-04
ACCUDEXA BONE DENSITOMETER (K981124)Schick Technologies, Inc.1998-06-04
VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K980959)Ge Medical Systems F.I. Haifa1998-06-04
CT SCOPE (K974344)Elscint, Inc.1998-06-03
JPACS (K980918)Philips Medical Systems (Cleveland), Inc.1998-06-03
EQUIDOSE SOLID STATE DIODE DETECTORS (K980826)Cii Mastek, Inc.1998-06-01
FOCUS RTP SYSTEM (K973936)Computerized Medical Systems, Inc.1998-06-01
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM (K981398)Interneuron Pharmaceuticals, Inc.1998-06-01
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM (K981626)Siemens Medical Solutions USA, Inc.1998-05-27
SONOS 5500 ULTRASOUND IMAGING SYSTEM (K980687)Hewlett-Packard Co.1998-05-22
DOWNSCAN LT (K974882)Merlin Engineering Works, Inc.1998-05-22
RADIOCAMERAS PATIENT POSITIONING SYSTEM (K980750)Surgical Navigation Technologies, Inc.1998-05-20
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER (K980125)Norland Corp.1998-05-20
FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 (K981404)Fukuda Denshi USA, Inc.1998-05-20
PINPOINT (K974513)Philips Medical Systems (Cleveland), Inc.1998-05-20
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS (K980837)Shimadzu Medical Systems1998-05-20
PROWESS PRO-SIM (K980379)Ssgi Prowess Systems1998-05-18
PHILIPS GYROSCAN NT RELEASE 6 SERIES (K980645)Philips Medical Systems North America, Inc.1998-05-11
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K980691)Hitachi Medical Systems America, Inc.1998-05-11
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER (K980809)Lumisys, Inc.1998-05-11
COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM (K981505)Sonosite,Inc.1998-05-08
SONOACE 6000/ ULTRAMARK 400 (K981510)Medison America, Inc.1998-05-08
VR NETSERVE (K980684)I.S.G. Technologies, Inc.1998-05-06
ECHOTECH 3D FREESCAN (K980308)Echotech 3D Imaging Systems GmbH1998-05-06
FACTS MONOBLOCK (K981267)Dynarad Corp.1998-05-06
VSS, VIRTUAL SIMULATION SYSTEM (K980629)Nucletron Corp.1998-05-06
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS) (K980715)Adac Laboratories1998-05-06
DIFFUSION PACKAGE / GYROSCAN NT (K973658)Philips Medical Systems North America, Inc.1998-05-06
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V (K980417)Medrad, Inc.1998-05-04
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS (K981280)Bayer Corp., Agfa Div.1998-04-30
CS2000 & CS2000 TOMO (K973834)Pausch Corp.1998-04-30
MEDRAD ATD-T INTERFACE DEVICE (K974438)Medrad, Inc.1998-04-30
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING (K980557)Siemens Medical Solutions USA, Inc.1998-04-24
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 (K973556)Imex Medical Systems, Inc.1998-04-24
ACCENT 16, ACCENT 22 (K980322)GE Medical Systems1998-04-24
CAPINTEC MODEL 292 ELECTROMETER (K980402)Capintec, Inc.1998-04-24
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 (K980851)Boston Scientific Corp1998-04-22
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM (K964001)Med Institute, Inc.1998-04-17
VIDAR VXR LS LASER FILM DIGITIZER (K974315)Vidar Systems Corp.1998-04-17
OLDELFT DIGIDELCA (K980296)Oldelft Corp. of America1998-04-17
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 (K973562)Imex Medical Systems, Inc.1998-04-15
PREMIER 7000 CTL SPINE COIL (K980157)Usa Instruments, Inc.1998-04-13
HISPEED QX/I CT SCANNER SYSTEM (K980176)General Electric Co.1998-04-13
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS (K980169)General Electric Co.1998-04-13
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) (K980235)Kci New Technologies, Inc.1998-04-09
LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 (K980091)Cosmaceutical Marketing, Inc.1998-04-09
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY (K980541)Barco NV Display Systems1998-04-09
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) (K980243)Parameter Developments, Inc.1998-04-03
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP (K980306)Elscint, Inc.1998-04-02
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM (K980860)Atlantis Diagnostics Intl., Inc.1998-04-02
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE (K980168)Analogic Corp.1998-04-02
LEKSELL GAMMAPLAN (K973441)Patterson Consulting Group, Inc.1998-04-01
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K980114)GE Medical Systems1998-03-30
TRIMAX RADIOGRAPHIC CASSETTE (K980722)Imation Corp.1998-03-23
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM (K974679)Medcon , Ltd.1998-03-23
LD2000 SERIES (K980565)General Scanning, Inc.1998-03-19
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER (K974544)Aloka Co., Ltd.1998-03-18
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE (K980241)Netco Communications Corp.1998-03-17
IMIX DIGITAL THORAX SYSTEM (K974863)Advanced Instrument Development, Inc.1998-03-17
DI-2000 (K980213)Lumisys, Inc.1998-03-17
KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER (K980118)Eastman Kodak Company1998-03-17
CARBON FIBER BREAST BOARD (K974703)Medtec, Inc.1998-03-10
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