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Radiology

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

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RecordFirmDate
CLINICAL DIAGNOSTIC SOFTWARE (K970288)Nuccardiac Software, Inc.1997-04-24
CALL-RAD PC TELERADIOLOGY (K964288)Pc Teleradiology1997-04-23
SONOS 2000, SONOS 2500 (M2406 A) (K964309)Hewlett-Packard Co.1997-04-22
EVT MARKER BOARD (K970608)Guidant Cardiac and Vascular Surgery1997-04-21
CT-MODELLER SYSTEM (K970617)Materialise NV1997-04-21
SOLO-SLED (K970090)Solo-Sled, LLC1997-04-21
JANUS I (K963863)3D Ultrasound, Inc.1997-04-21
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS (K970734)Siemens Medical Solutions USA, Inc.1997-04-21
SINUSCAN 102/SINUSPRINT (K960421)Ferguson Medical1997-04-16
PIXI BONE DENSITOMETER (K970224)Lunar Corp.1997-04-16
STATNET (K970525)Gorca Systems, Inc.1997-04-16
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS (K964307)Lunar Corp.1997-04-16
EXL-12SP,12DP,15DP,20DP LINAC (K970137)Mitsubishi Electronics America, Inc.1997-04-15
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA) (K970128)Park Medical Systems, Inc.1997-04-11
DOWNSCAN 120 (K970451)Merlin Engineering Works, Inc.1997-04-07
IMEX FUTURALDOP PRO (K970156)Imex Medical Systems, Inc.1997-04-04
COMPUTED TOMOGRAPHY X-RAY SYSTEM (K970606)GE Medical Systems1997-04-04
PICTURE ARCHIVING & COMMUNICATIONS DEVICE (K970534)Multimedia Solutions1997-04-04
KODAK EKTASIAN HG FILM (EHG-15) (K970154)Eastman Kodak Company1997-04-04
ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM (K963616)Aloka Co., Ltd.1997-04-03
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM (K962627)Siemens Medical Solutions USA, Inc.1997-04-03
LINAC SCALPEL FLOORSTAND (K964517)Surgical Navigation Technologies, Inc.1997-04-01
UPSCAN 120 (K970450)Merlin Engineering Works, Inc.1997-04-01
FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667 (K970349)Fujifilm Medical System U.S.A., Inc.1997-03-31
E. CAM PROFILE ATTENUATION CORRECTION (K963983)Siemens Corp.1997-03-31
ACCESSPOINT, MED E-MAIL, DICOM READER (K963936)Biosound, Inc.1997-03-31
ARTOSCAN M (K963262)Biosound, Inc.1997-03-28
BIO-BINKI (K961782)Biomni Medical Systems, Inc.1997-03-28
GYREX 2T-PRESTIGE (K970005)Elscint, Inc.1997-03-28
DOCTORS REVIEW SYSTEM (K970402)Digisonics, Inc.1997-03-26
LEVEL 10 HDI (K961459)Advanced Technology Laboratories, Inc.1997-03-26
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS (K962010)Philips Medical Systems (Cleveland), Inc.1997-03-21
PHILIPS EASY DIAGNOST (K970640)Philips Medical Systems North America, Inc.1997-03-21
DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) (K964167)Multidata Systems International Corp.1997-03-21
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 (K970293)Fujifilm Medical System U.S.A., Inc.1997-03-21
PHILIPS SONO DIAGNOST 800 (K963706)Hewlett-Packard Co.1997-03-19
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM (K953902)Medical Marketing Intl., Inc.1997-03-19
AMICAS WEB/INTRANET IMAGE SERVER (K970064)Autocyt Group, Inc.1997-03-17
VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE (K963315)Vingmed Sound, Inc.1997-03-17
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM (K970034)Hewlett-Packard Co.1997-03-17
CONTRAST MEDIA SET (K955179)B.Braun Medical, Inc.1997-03-12
TARGOGRID (K970037)Daum GmbH1997-03-12
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) (K965161)Sectra-Imtec AB1997-03-12
SERIES 7600 MOBILE DIGITAL C-ARM (K970063)Ge Dec Medical Systems1997-03-11
DIFFUSER PANEL (K970240)Focused Viewer, Inc.1997-03-11
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER (K965004)Siemens Medical Solutions USA, Inc.1997-03-11
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION (K963273)Smv America1997-03-11
PVK-720ST ENDOCAVITARY TRANSDUCER (K964865)Toshiba America Medical Systems, In.C1997-03-10
AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS (K964910)Alpha-Omega Services, Inc.1997-03-10
ANATOM 2000 (K964890)Analogic Corp.1997-03-06
PHASED ARRAY TRANSDUCER - - PSK-20CT (K970047)Toshiba America Medical Systems, In.C1997-03-04
MD-1835 (K964806)Fischer Imaging Corp.1997-03-04
ISOCAM II (DUAL HEAD GAMMA CAMERA) (K964834)Park Medical Systems, Inc.1997-02-28
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A (K964820)Us Asia Instruments, Inc.1997-02-28
UHE COLLIMATOR (210591) (K963406)Philips Medical Systems (Cleveland), Inc.1997-02-26
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: (K964813)Medical Advances, Inc.1997-02-26
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) (K964990)Hitachi Medical Systems America, Inc.1997-02-26
VIPOR UNIT (K964322)Tilane Corp.1997-02-26
HI-STAR MRI IMAGING SYSTEM (K964778)Health Images, Inc.1997-02-24
KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER (K964752)Philips Medical Systems (Cleveland), Inc.1997-02-24
RHEO DOPPLEX II (RD 2) (K964699)Huntleigh Technology, Inc.1997-02-21
PRISM XPVT SYSTEM (210823) (K964712)Philips Medical Systems (Cleveland), Inc.1997-02-21
ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) (K961073)Atlantis Diagnostics Intl., Inc.1997-02-19
COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER (K940942)Medison America, Inc.1997-02-19
MODELS EXL AND EXS EXTREMITY COIL SET (K964668)Mri Devices Corp.1997-02-18
OASIS (K964658)Sonotech, Inc.1997-02-14
BEAM BLOCK TRAYS (K964840)Aktina Medical Physics Corp.1997-02-11
PHASED ARRAY NECK COIL (K964678)Philips Medical Systems (Cleveland), Inc.1997-02-11
MATRIX 3000 FLEXIBLE SPINE COIL (K964753)Us Asia Instruments, Inc.1997-02-11
UNIVISION ECHOCARDIOLOGY SYSTEM (K964803)Network Concepts, Inc.1997-02-11
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL (K964854)Medrad, Inc.1997-02-11
THE NOMOS MINICRANE (K964740)Nomos Corp.1997-02-11
ULTRASOUND SYSTEM MODEL UF-3500 (K955543)Fukuda Denshi USA, Inc.1997-02-11
SOMATOM PLUS 4 CT SCANNER (K964747)Siemens Medical Solutions USA, Inc.1997-02-10
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE (K964626)Philips Medical Systems (Cleveland), Inc.1997-02-10
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE (K961974)Pentax Precision Instrument Corp.1997-02-10
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE (K964647)North American Scientific, Inc.1997-02-10
GAMMA GUIDANCE SYSTEM (K961321)Radiation Monitoring Devices, Inc.1997-02-10
SHEATHES (NON-LATEX) (K963831)Medical Resources1997-02-10
PROTEC (1024) (K963730)Proportional Technologies, Inc.1997-02-10
MLC FIT (K962335)Impac Medical Systems, Inc.1997-02-06
TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM (K963302)Tayman Medical, Inc.1997-02-06
PLANNED SOPHIED CLASSIC (K962105)Planmed OY1997-02-05
MRT-35A V9.0 (K964608)Toshiba America Mri, Inc.1997-02-04
PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM (K964485)Eliav , Ltd.1997-02-04
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (K965105)U.S. Imaging Tables, Inc.1997-01-30
GE STERILE DISPOSABLE EQUIPMENT COIL COVER (K964141)Contour Fabricators, Inc.1997-01-30
LR 5200 LASER FILM RECORDER (K964414)Bayer Corp., Agfa Div.1997-01-27
FLUOROVIEW SERIES FLUOROSCOPIC TABLES (K965096)U.S. Imaging Tables, Inc.1997-01-27
KODAK MINILOADER(2000) (K970059)Eastman Kodak Company1997-01-27
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION (K964746)GE Medical Systems1997-01-24
PROFILE 70000 QUADRATURE VOLUME NECK COIL (K964531)Us Asia Instruments, Inc.1997-01-24
TILTING RADIOGRAPHIC TABLE (REMOTE) (K963851)Acoma Medical Imaging, Inc.1997-01-23
DIASONICS ITNRAOPERATIVE PROBES (K961002)Diasonics Ultrasound1997-01-22
NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM (K962796)Medasonics, Inc.1997-01-21
XRT-7.0 (K964583)Elscint, Inc.1997-01-17
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K964306)General Electric Co.1997-01-17
DIGITAL IMAGE ANALYSIS SYSTEM (K962153)University of Washington1997-01-17
DIGISCOPE RX-2 (9 OPTION) (K965013)Medirex, Inc.1997-01-17
IPU RX-2 (K964327)Medirex, Inc.1997-01-17
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