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Radiology

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

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RecordFirmDate
FUJI FCR IMAGE PROCESSING UNIT IP-U515 (K942561)Fujifilm Medical System U.S.A., Inc.1994-12-23
TUNGSTEN EYESHIELD (K943011)Medtec, Inc.1994-12-23
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K944112)GE Medical Systems1994-12-22
UNITONE (K934572)Scitex Corporation , Ltd.1994-12-15
RF DRIVER, RADIO FREQUENCY DRIVER (K943406)Pro-Comm, Inc.1994-12-15
HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER (K944523)Humphrey, Inc.1994-12-15
MERIT (O.1T MR SYSTEM) (K943415)Philips Medical Systems (Cleveland), Inc.1994-12-15
MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 (K945238)F. Walter Hanel GmbH1994-12-15
NRF SYSTEM (K944973)Philips Medical Systems (Cleveland), Inc.1994-12-14
PHILIPS BUCKY DIAGNOST FAMILY (K945278)Philips Medical Systems North America, Inc.1994-12-14
SII 525 MS (K945709)Scott Imaging Intl., Inc.1994-12-14
RHODIUM FILTER (K945272)Lorad Corp.1994-12-14
SII 360 MS (K945708)Scott Imaging Intl., Inc.1994-12-14
BES - BREATH EXPOSURE SYNCHRONIZER (K942581)The Henry G. Dietz Co., Inc.1994-12-12
VERSION 5 OPERATING SYSTEM SOFTWARE (K943799)Hitachi Medical Systems America, Inc.1994-12-09
TOMO-LINK (K944967)GE Medical Systems1994-12-09
MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM (K940660)Victoreen, Inc.1994-12-09
LENZAR REMOTE ACQUISITION SYSTEM (K941224)Lenzar Electrooptics, Inc.1994-12-09
COMPAS (K945483)General Electric Co.1994-12-09
PHILIPS ULTRASOUND P800 IMAGING SYSTEM (K935923)Hewlett-Packard Co.1994-12-08
MODEL #300TO3500 SHOULDER COIL (K942874)Medic, Inc.1994-12-08
PANORAMIC CORPORATION HDLX (K943532)Panoramic Corp.1994-12-07
HP BACK POINTER SYSTEM (K943802)Medtec, Inc.1994-12-07
DIAGNOSTIC ULTRASOUND IMAGING CATHETER (K940108)Boston Scientific Corp1994-12-07
MEDVISION ENVIROMENT/MEDVISION 2.0 (K942861)Evergreen Technologies, Inc.1994-12-07
MOTORIZED DEPTH DOSE APPARATUS (K943199)Medtec, Inc.1994-12-07
MODEL #700TO3500 NECK/ABDOMINAL COIL (K942873)Medic, Inc.1994-12-02
MODEL #900TO3500 HEAD/NECK COIL (K942875)Medic, Inc.1994-12-02
URO - ELITE TABLE ACCESSORIES (K944987)Philips Medical Systems (Cleveland), Inc.1994-11-30
MEDRAD COUNTERPOISE SYSTEM (K944983)Medrad, Inc.1994-11-29
ADVANCE ANALYSIS SOFTWARE (K941223)General Electric Co.1994-11-29
HEAD AND NECK COIL FOR THE GYREX 2T-DLX (K943320)Elscint, Inc.1994-11-29
V-MAX OPTIONS (K943447)Philips Medical Systems (Cleveland), Inc.1994-11-28
RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (K943926)Philips Medical Systems (Cleveland), Inc.1994-11-28
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE) (K940534)Philips Medical Systems, Inc.1994-11-22
CEMAX SCANLINK V (K943357)Cemax, Inc.1994-11-22
BLOCKING TRAY (K944315)Medtec, Inc.1994-11-22
MCI OPTONIX CASSETTE OKAMOTO CASSETE (K945039)Mci Optonix, Inc.1994-11-22
INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER (K940671)Interspec, Inc.1994-11-22
IMAGING WORKBENCH (K943383)Brit Systems, Inc.1994-11-22
AD/V IMAGEPLEX(TM) (K943158)Adaptive Video, Inc.1994-11-22
PAPER FILM (K940664)Astro Office Products, Inc.1994-11-15
SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. (K931021)Shimadzu Medical Systems1994-11-14
ULTRAPRO WORKSTATION (K942917)Ramsoft, Inc.1994-11-14
ULTRASOUND PROBE DRAPE (K940151)Hydro-Med Products, Inc.1994-11-14
GEMNET (K943355)GE Medical Systems1994-11-07
SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION (K941093)Smartpacs1994-11-07
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF) (K940541)Siemens Medical Solutions USA, Inc.1994-11-07
BENNETT X-RAY DIGITAL SPOT IMAGER (K935428)Bennett X-Ray Technologies1994-11-01
ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) (K930964)Acuson Corp.1994-10-26
ACUSON MODEL 2001 (K934915)Acuson Corp.1994-10-21
R AND D BATTERIES (K935427)R & D Batteries, Inc.1994-10-21
ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION (K941652)Aloka Co., Ltd.1994-10-21
PHILIPS TOMOSCAN SR5000 (K944326)Philips Medical Systems North America, Inc.1994-10-21
DFS-2100 (K932760)Dba Systems, Inc.1994-10-20
SSA-380A (K933743)Toshiba America Medical Systems, In.C1994-10-20
MULTIPLE ED1600 SERIES RADIATION SHIELDS (K944772)Image Diagnostics, Inc.1994-10-20
CARPAL BOX (K936087)Innovative Medical Technologies, Inc.1994-10-20
MRT-150A (K943021)Toshiba America Mri, Inc.1994-10-14
LORAD TRANSPO (K934868)Lorad Corp.1994-10-14
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR (K942731)Shimadzu Corp.1994-10-13
PHILIPS TOMOSCAN SR 4000 (K936272)Philips Medical Systems North America, Inc.1994-10-11
PEGASUS (K935009)Advanced Technology Laboratories, Inc.1994-10-11
PINNACLE 3 (K926008)Adac Laboratories1994-10-04
SWEMED NEEDLE GUIDE (K925999)Swemed Lab Intl.1994-10-03
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER (K933916)Ausonics Pty , Ltd.1994-10-03
ORACLE MRI WHOLE BODY MR IMAGING SYSTEM (K942953)Otsuka Electronics USA, Inc.1994-09-30
DIGITAL I.D. CAMERA (K942883)Miles Inc., Agfa Division1994-09-30
HP 77010CF (K943634)Hewlett-Packard Co.1994-09-30
ISOCAM II (DUAL HEAD GAMMA CAMERA) (K940487)Independent Scintilation Imaging Systems, Inc.1994-09-30
CARDIOVASCULAR MEASUREMENT SYSTEM-CMS (K940172)Medis Medical Imaging Systems, Inc.1994-09-29
SONOQUICK ULTRASOUND GEL (K931908)Sonomed Technology, Inc.1994-09-29
CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL (K931909)Sonomed Technology, Inc.1994-09-29
BETA C COUNTER (K943072)Capintec Instruments, Inc.1994-09-29
THE OSTEOREPORT (K934040)Woodson and Associates, LLC1994-09-26
QUAD PELVIS COIL (K943321)Hitachi Medical Systems America, Inc.1994-09-23
PATLAK & FDG AUTORADIOGRAPHIC (K936001)GE Medical Systems1994-09-23
FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET (K926019)Norland Corp.1994-09-23
VARIAN ORIGAMI, VERSION 1.0 (K932501)Varian Assoc., Inc.1994-09-23
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD (K943805)General Electric Co.1994-09-23
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER (K942146)Siemens Medical Solutions USA, Inc.1994-09-23
VARIAN RMS-2000, RELEASE 2.5 (K930513)Varian Assoc., Inc.1994-09-23
CYTOGUIDE STEREOTATIC BIOPSY SYSTEM (K933430)Gold Coast Imaging, Inc.1994-09-22
HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION (K934041)Hewlett-Packard Co.1994-09-22
MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1 (K942776)Otsuka Electronics USA, Inc.1994-09-21
3M 1152 LASER IMAGER (K936152)3M Information,Imaging and Electronic Sector1994-09-21
SOMATOM PROJECT 059 (K941546)Siemens Corp.1994-09-20
MICRO X-80 HF (K944149)Fischer Imaging Corp.1994-09-16
3M 1154 LASER IMAGER (K936142)3M Information,Imaging and Electronic Sector1994-09-16
STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM (K924685)Leibinger GmbH1994-09-16
MICRO X-50 HF (K944147)Fischer Imaging Corp.1994-09-16
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX (K934987)Elscint, Inc.1994-09-16
MICRO X-30HF (K944148)Fischer Imaging Corp.1994-09-16
CEQUAL-QUANTITATIVE ANALYSIS (K942363)Nuccardiac Software, Inc.1994-09-16
VISIONLINK DICOM MODULE (K942860)Evergreen Technologies, Inc.1994-09-16
MODEL #310T03500 WRIST COIL (K942355)Medic, Inc.1994-09-16
MICRO X-65 HF (K944150)Fischer Imaging Corp.1994-09-16
MT-300 CASSETTE HOLDER (K941600)Medtec, Inc.1994-09-16
PHILIPS THORAVISION (K931071)Philips Medical Systems, Inc.1994-09-15
MAMMOMAT 300 AND MAMMOMAT 3000 (K932672)Siemens Medical Solutions USA, Inc.1994-09-14
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