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Radiology

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

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RecordFirmDate
ID. STORE (RELEASE 2.0) (K973413)I.S.G. Technologies, Inc.1997-11-25
SMARTVIEW OPTIONS FOR HISPEED CT/I (K973168)GE Medical Systems1997-11-21
VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE (K973889)Varian Medical Systems, Inc.1997-11-21
DIGITAL ADD-ON BUCKY (K970136)Swissray Teleray AG1997-11-21
PROSTATE SEEDING NEEDLE (K973184)Promex, Inc.1997-11-21
GIOTTO HT (K973856)Sitco, Inc.1997-11-21
MACOM (K973148)A.Stein - Regulatory Affairs Consulting1997-11-20
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (K973162)Hogan & Hartson1997-11-20
MEDIMAGE (K972215)Vepro - Computersysteme GmbH1997-11-19
IMATION SE-204 LASER IMAGER (K972822)Imation Enterprises Corp.1997-11-19
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE (K972517)Lunar Corp.1997-11-18
SENSOR PAD (K973450)Inventive Products, Inc.1997-11-14
IMAGING JET SYSTEM (K970782)General Robotic Devices, Inc.1997-11-13
SNT LINAC ACCESSORIES (K971893)Surgical Navigation Technologies, Inc.1997-11-13
REALVIEW TELEMEDICINE SYSTEM (K973065)Vcom Systems, Inc.1997-11-13
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) (K973131)Siemens Medical Solutions USA, Inc.1997-11-12
PLANMED CYTOGUIDE (K973493)Planmed OY1997-11-10
RAVEN DRY PRINTER (K972660)Sterling Diagnostic Imaging, Inc.1997-11-10
MAMMOTEST ADAPTER DRIVER (K973400)Fischer Imaging Corp.1997-11-10
PHILIPS INTEGRIS V5000 AND BV5000 (K973482)Philips Medical Systems North America, Inc.1997-11-10
SIREMOBIL CO2 (K973598)Siemens Medical Solutions USA, Inc.1997-11-10
INFLATABLE POSITIONING CUSHIONS (K973915)Kci New Technologies, Inc.1997-11-10
REALTIME 3D DIAGNOSTIC WORKSTATION (K973010)Siemens Medical Solutions USA, Inc.1997-11-10
DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) (K973081)Howtek, Inc.1997-11-05
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM (K973079)Acuson Corp.1997-11-05
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS (K972903)Imatron, Inc.1997-11-04
CONTROL SYRINGE (K972655)Medical Specialties Intl., Inc.1997-11-04
APOLLO (K972882)Norland Corp.1997-10-31
MEDSTATION (K973090)Program S.R.L.1997-10-28
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A (K972271)Ml Strategies, Inc.1997-10-28
XPLAN-1 (K972905)Radionics Software Applications, Inc.1997-10-28
HELIOS LASER IMAGER 1417 (K973028)Sterling Diagnostic Imaging, Inc.1997-10-28
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) (K973422)Dejarnette Research Systems1997-10-28
VOX/BASE FOR WINDOWS (K972933)J-Mac System, Inc.1997-10-27
BRAINSCAN CONFORMAL RT MODULE (K971367)Brainlab AG1997-10-27
MCD-AC (K971980)Adac Laboratories1997-10-23
BANG POLYMER GEL DOSIMETER, BANG 533 (K972804)Mgs Research, Inc.1997-10-23
STRAIT'MAP OPTION (K973368)Ge Medical Systems, Inc.1997-10-17
DRTS REMOTE CONTROL DRAPE (K973067)Minrad, Inc.1997-10-16
TBI STAND (K972709)Mick Radio-Nuclear Instruments, Inc.1997-10-16
LEGACY/LEGACY-D TABLE (K973039)GE Medical Systems1997-10-16
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM (K972229)Heartware, Inc.1997-10-16
ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION (K972879)Imatron, Inc.1997-10-15
ESTEEM 1.5T MRI SYSTEM (K972826)Elscint Mr, Inc.1997-10-15
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM (K972973)Perception, Inc.1997-10-15
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER (K972686)Smv America1997-10-14
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR (K972130)Fairmontmedical1997-10-09
MAMMOLOADER BY C.M.A. SRL (K973125)C.M.A.1997-10-08
DRTS IMAGE INTENSIFIER DRAPE (K973073)Minrad, Inc.1997-10-08
DAR-3000B (K973342)Shimadzu Corp.1997-10-08
ACU-RAY HF SERIES PORTABLE X-RAY UNIT (K972204)Sterne Equipment Co., Ltd.1997-10-08
AMBER DU (K973219)Oldelft Corp. of America1997-10-08
CM & CM DS-7 (K963914)Konica Medical Corp.1997-10-08
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX (K973329)Shimadzu Medical Systems1997-10-08
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH (K973327)Shimadzu Medical Systems1997-10-08
MD100 & MM150 (K963913)Konica Medical Corp.1997-10-08
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) (K972847)Eastman Kodak Company1997-10-07
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM (K964617)GE Medical Systems1997-10-03
EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE (K965226)Lunar Corp.1997-10-03
HELAX-VISIR (K972617)Helax AB1997-10-01
NEEDLE GUIDE/GRID (K973362)Protek Medical Products, Inc.1997-10-01
MIRAGE (K972886)Segami Corp., Inc.1997-10-01
COLORPOINT OR PROFESSIONAL COLORPOINT (K971760)Seiko Instruments USA, Inc.1997-10-01
KINEMATIC POSITIONERS (K972704)Ge Medical Systems, Inc.1997-09-29
OPTIVIEW (K972520)Optimed Technologies, Inc.1997-09-29
MULTISPECT 2 511 KEV COLLIMATOR (K972360)Siemens Medical Solutions USA, Inc.1997-09-23
IMNET DICOM NETWORK AGENT (K972366)Imnet Systems, Inc.1997-09-23
ADVANTAGE WINDOWS VOLUME RENDERING OPTION (K972399)Ge Medical Systems, Inc.1997-09-23
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) (K972592)Elscint, Inc.1997-09-15
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K972296)Ge Medical Systems, Inc.1997-09-15
FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS) (K972256)Fujifilm Medical System U.S.A., Inc.1997-09-12
CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 (K972442)Continental X-Ray Corp.1997-09-11
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (K972380)Eastman Kodak Company1997-09-11
MULTIDOS, QC6PLUS (K972211)Ptw-New York Corp.1997-09-10
0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER (K972212)Ptw-New York Corp.1997-09-10
CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER (K972509)Nuccardiac Software, Inc.1997-09-08
DIGITIZER DIRECTOR (HSC025-01) (K972191)Howtek, Inc.1997-09-08
LANTIS TREATSTATION (K972275)Siemens Medical Solutions USA, Inc.1997-09-08
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM (K960527)GE Medical Systems1997-09-08
IMATION SE-196 LASER IMAGER (K972163)Imation Corp.1997-09-05
P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 (K970464)Northwest Medical Physics Equipment, Inc.1997-09-05
ALPHA 7000 QUADRATURE WRIST COIL (K972205)Usa Instruments, Inc.1997-09-05
E. CAM COINCIDENCE MODE (CM) (K970627)Siemens Medical Solutions USA, Inc.1997-09-04
FLY THROUGH (K971717)Siemens Medical Solutions USA, Inc.1997-09-03
VIEW ARCHIVING STATION (K971176)Electromed Intl., Ltd.1997-09-03
PHILIPS EASYVISION (K972103)Philips Medical Systems North America, Inc.1997-09-02
ARRIPRO 35 ST/TV (K973115)Arnold & Richter Cine Technik1997-09-02
GYREX PRIMA 1TG 1.0T MRI SYSTEM (K970990)Elscint Mr, Inc.1997-08-25
KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER (K971973)Eastman Kodak Company1997-08-25
VIEWCATH 3-D CATHETER PULLBACK (K971397)Quinton, Inc.1997-08-25
DTX-200 BONE DENSITOMETER (K964562)Osteometer Meditech A/S1997-08-22
AXT 150M MANUAL COLLIMATOR (AXT 150M) (K972966)Applied X-Ray Technologies, Inc.1997-08-21
INSIGHT 7000 PHASED ARRAY TORSO COIL (K972340)Usa Instruments, Inc.1997-08-21
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM (K971894)Eastman Kodak Company1997-08-20
ASSET APOLLO (K971884)Philips Medical Systems (Cleveland), Inc.1997-08-20
TDK MEDICAL GRADE CD-R (K971848)Tdk Electronics Corporation of America1997-08-15
VARIAN RADIATION THERAPY IMAGING SYSTEM (K971839)Varian Medical Systems, Inc.1997-08-15
DEVMED STEPPING AND STABILIZING SYSTEM (K972152)Devmed Corp.1997-08-15
ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM (K972465)Aloka Co., Ltd.1997-08-15
PIVOTING COMPENSATING FILTERS FOR THE HEAD (K972766)Octostop, Inc.1997-08-14
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