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Radiology

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

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RecordFirmDate
HELAX-IMCON, VERSION 1.0 (K982857)Helax AB1998-11-04
CT BIOPSYVIEW (K983140)Philips Medical Systems North America, Inc.1998-11-04
SILHOUETTE VR (K982955)GE Medical Systems1998-11-04
CANON X-RAY DIGITAL CAMERA CXDI-11 (K981556)Canon USA, Inc.1998-11-04
DIGIRAD 2020TC SPECT IMAGING SYSTEM (K982855)Digirad Corp.1998-11-04
MITRA IMAGING INC. EXHIBIT (K982769)Mitra Imaging, Inc.1998-11-03
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA (K982921)Medrad, Inc.1998-11-03
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC (K982959)Medrad, Inc.1998-11-03
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER (K981886)Cook, Inc.1998-11-03
NEEDLE GUIDE (K983621)Remington Medical, Inc.1998-11-03
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER (K980576)Varian Medical Systems, Inc.1998-11-02
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC (K982919)Medrad, Inc.1998-11-02
MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC (K982932)Medrad, Inc.1998-11-02
PHILIPS DUO DIAGNOST (K983069)Philips Medical Systems North America, Inc.1998-11-02
RT DESKTOP (K982713)Elekta Oncology Systems, Ltd.1998-11-02
XCT 2000 L PQCT BONE DENSITOMETER (K983273)Medical Systems, Inc.1998-10-29
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM (K983436)Gammamed USA1998-10-29
RESTGRID PACKAGE/GYROSCAN NT (K982834)Philips Medical Systems North America, Inc.1998-10-29
WISE (II) IMAGE MANAGEMENT SYSTEM (K983447)Sectra-Imtec AB1998-10-29
X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID (K982824)I.E.D., Inc.1998-10-29
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC (K982916)Medrad, Inc.1998-10-29
OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE (K982733)The Olympus Optical Co.1998-10-28
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM (K981528)Siemens Medical Solutions USA, Inc.1998-10-28
MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 (K982624)Med-Tec,Inc.1998-10-26
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE (K982725)Olympus America, Inc.1998-10-23
JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 (K982761)Chamco, Inc.1998-10-22
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER (K980590)Varian Medical Systems, Inc.1998-10-22
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER (K980601)Varian Assoc., Inc.1998-10-21
ASTEION CT SCANNER, TSX-021A (K982787)Toshiba America Medical Systems, In.C1998-10-21
RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE (K982862)Applicare Medical Imaging, B.V.1998-10-21
DX-480, ADD ON DIGITAL IMAGER (K981880)Wuestec Medical, Inc.1998-10-20
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL (K982772)Ge Medical Systems, Inc.1998-10-15
FILM DIGITIZER MODEL 2905 (K982785)Array Corp.1998-10-15
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY (K981597)Radionics, Inc.1998-10-09
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS (K983327)Siemens Medical Solutions USA, Inc.1998-10-09
BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K982820)Barco NV Display Systems1998-10-08
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64 (K983222)Medical Advances, Inc.1998-10-08
E.CAM EXTRA HIGH ENERGY COLLIMATOR (K982387)Siemens Medical Solutions USA, Inc.1998-10-06
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY (K983109)Medical Advances, Inc.1998-10-06
ULTRAPRO MODEL 98 (K982563)Ramsoft, Inc.1998-10-06
PHILIPS TOMOSCAN CS (K982631)Philips Medical Systems, Inc.1998-10-06
7250 ULTRASOUND IMAGING SYSTEM (K982444)Biosound Esaote, Inc.1998-10-06
BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE (K982690)Barco N.V.1998-10-06
DIGITAL RADIOGRAPHIC IMAGING SYSTEM (K982196)GE Medical Systems1998-10-06
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL (K982583)Shimadzu Corp.1998-10-05
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS (K982349)Siemens Medical Solutions USA, Inc.1998-09-30
EAGLESOFT CHAIRSIDE (K982422)Eaglesoft, A Patterson Co.1998-09-30
EXTRACRANIAL RADIOTHERAPY SYSTEM (K982463)Howmedica, Inc.1998-09-30
XKNIFE-4 (K981055)Radionics, Inc.1998-09-29
PHILIPS OMNIDIAGNOST (K982993)Philips Medical Systems, Inc.1998-09-29
AUTOMATED MEDICAL REPORT WRITER (K981553)Woodson and Associates, LLC1998-09-29
PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM (K981834)Perception, Inc.1998-09-29
DYNAMIC SHIELDING RADIATION TABLE (K982446)American Biophysics, Inc.1998-09-29
COMBISON 530D WITH POWER DOPPLER MODE (K974813)Medison America, Inc.1998-09-29
PGK DEVICE (MODIFIED) (K980997)Pgk, Inc.1998-09-28
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A (K982300)Toshiba America Medical Systems, In.C1998-09-25
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C (K982427)Trex Medical Corp.1998-09-23
ULTRA-COVER PU-TRANSDUCER COVER (K981069)International Medical Products B.V.1998-09-23
ECTON LYNX ULTRASOUND SYSTEM (K982800)Ecton, Inc.1998-09-22
INSTACINE D-2000 (K983088)Fidelity Medical, Inc.1998-09-22
CAREGRAPH (K982319)Siemens Medical Solutions USA, Inc.1998-09-22
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D (K982496)Medical Advances, Inc.1998-09-18
HAMAMATSU PET SCANNER, MODEL SHR-22000 (K982171)Hamamatsu Photonics K.K.1998-09-17
PICTOOLS MEDICAL TOOL KIT MODEL 1.0 (K982146)Pegasus Imaging Corp.1998-09-14
DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) (K982120)Trex Medical Corp.1998-09-10
FLOW 7000 PERIPHERAL VASCULAR COIL (K982339)Usa Instruments, Inc.1998-09-04
VOLUMAX CT IMAGING SYSTEM (K982060)Elscint, Inc.1998-09-02
NUCAMMA RX (K982045)Is2 Research, Inc.1998-09-02
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K982157)Field Effects1998-09-02
PHILIPS BV300 SERIES RELEASE 2.1 (K982706)Philips Medical Systems, Inc.1998-09-02
ACQPLAN (K974770)Philips Medical Systems (Cleveland), Inc.1998-09-02
NUCAMMA R+ (K982044)Is2 Research, Inc.1998-09-02
VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM (K982345)Cardiac Mariners, Inc.1998-09-01
IMAGE POST-PROCESSING TECHNIQUES (K980831)Philips Medical Systems (Cleveland), Inc.1998-08-27
AU5 ULTRASOUND IMAGING SYSTEM (K980468)Biosound Esaote, Inc.1998-08-26
AQUILION CT SCANNER, MODEL TSX-101A (K982265)Toshiba America Medical Systems, In.C1998-08-26
C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (K982442)Care Wise Medical Products Corp.1998-08-25
PEDIATRIC INSTATRAK SYSTEM (K981998)Visualization Technology, Inc.1998-08-21
SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, (K974269)Medison America, Inc.1998-08-21
ULTRA IMAGE AND ULTRA SCAN (K981028)Sonotech, Inc.1998-08-21
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS (K982004)General Electric Co.1998-08-18
DPX-RX BONE DENSITOMETER (K982267)Lunar Corp.1998-08-18
INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD (K974588)Rimed , Ltd.1998-08-07
DIAGNOSTIC ULTRASOUND SYSTEM (K982498)Volumetrics Medical Imaging, Inc.1998-08-07
CAREDOP II (K982635)Nicolet Biomedical1998-08-07
SONOPSY LA SYSTEM (K980423)Neovision Corp.1998-08-07
IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW (K981790)Elekta Oncology Systems, Ltd.1998-08-07
ORTHOVU-1000 (K981898)Magnevu1998-08-03
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 (K981397)Toshiba America Medical Systems, In.C1998-07-31
IMAGEQUEST (K974707)Visual Med, Inc.1998-07-31
OUTLOOK LARGE PHASED ARRAY NECK COIL (K981959)Philips Medical Systems (Cleveland), Inc.1998-07-31
MX MEVATRON (K982513)Siemens Medical Solutions USA, Inc.1998-07-31
GENESIS IMRT LINEAR ACCELERATOR (K982502)Siemens Medical Solutions USA, Inc.1998-07-31
IMAGYN 125 I SEED, MODEL IS 125 (K982421)International Isotopes, Inc.1998-07-31
EUP-OL334 LAPARASCOPICPROBE (K981434)Hitachi Medical Corp. of America1998-07-27
PHOTON RADIOSURGERY SYSTEM PRS400 (K980526)Pec Photoelectron Corp.1998-07-27
MOBETRON (K981112)Intraop Medical, Inc.1998-07-24
PRO VISION (K980648)Algotec Systems, Ltd.1998-07-20
NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM (K981424)Nomos Corp.1998-07-17
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ (K981641)Instrumentarium Corp.1998-07-17
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