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Radiology

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

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RecordFirmDate
ULTRASOUND SCANNER, TYPE 1101 (K002085)B & K Medical A/S2000-08-01
EXPLORER CVS TRANSCRANIAL DOPPLER (K990517)Diagnostic Medical Systems2000-08-01
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM (K002185)Medison America, Inc.2000-08-01
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM (K001400)Siemens Medical Solutions USA, Inc.2000-08-01
MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001753)Barco NV Display Systems2000-07-27
MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001748)Barco NV Display Systems2000-07-27
MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM (K001750)Barco NV Display Systems2000-07-21
PROTON BEAM THERAPY SYSTEM (PBTS) (K992414)Optivus Technology, Inc.2000-07-21
MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001751)Barco NV Display Systems2000-07-19
MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001752)Barco NV Display Systems2000-07-19
MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001754)Barco NV Display Systems2000-07-19
MEDICAL IMAGE MERGE (MIM) (K001276)Syntermed, Inc.2000-07-17
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE (K001582)Usa Instruments, Inc.2000-07-17
PHARMASEED, MODEL BT-125-3 (K994018)Syncor Pharmaceuticals, Inc.2000-07-17
PHARMASEED, MODEL BT-103-3 (K994016)Syncor Pharmaceuticals, Inc.2000-07-14
HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING (K002003)Atl Ultrasound, Inc.2000-07-13
POCKET ULTRASONIC PACHYMETER (K993674)Quantel Medical2000-07-13
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001747)Barco NV Display Systems2000-07-13
BRAINSCAN (K994413)Brainlab AG2000-07-13
PEDIATRIC REFERENCE DATA (K001812)Lunar Corp.2000-07-10
LUNAR REPORT GENERATOR II (K001756)Lunar Corp.2000-07-06
HITACHI AIRIS II (K001334)Hitachi Medical Systems America, Inc.2000-07-06
MODIFICATION TO E-SCAN (K001894)Biosound Esaote, Inc.2000-07-06
LIFERX (K001596)Bowdengs Technologies, LLC2000-07-06
UNICORN MODEL SYS0630 (K001888)Danish Diagnostic Development A/S2000-06-30
VSCORE WITH EKG SIGNAL GATING (K001682)Vital Images, Inc.2000-06-30
NICOLET EME LEGEND TC22 (K993939)Nicolet Biomedical2000-06-29
XPLAN 2.1 (K001700)Radionics, Inc.2000-06-28
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES (K001517)Shimadzu Corp.2000-06-27
VARIS 1.4G (K001643)Varian Medical Systems, Inc.2000-06-23
NOVAC7 (K990209)Hitesys S.P.A.2000-06-22
ULTRASIM CT SYSTEM (K001088)Philips Medical Systems (Cleveland), Inc.2000-06-22
3D-MSPECT (K001026)The Reagents of the University of Michigan2000-06-20
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL (K001312)Igc-Medical Advances, Inc.2000-06-20
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 (K001711)Agilent Technologies, Inc.2000-06-20
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY (K993176)Norland Medical Systems, Inc.2000-06-20
BREAST IMMOBILIZATION DEVICE MR-BY 160 (K001303)Mri Devices Corp.2000-06-20
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA (K001713)Mri Devices Corp.2000-06-14
DIGITAL INTEGRATION SYSTEM, DIS2000 (K001012)Wellington Medical Systems, Inc.2000-06-13
PHARMASEED, MODEL BT-125-2 (K993701)Syncor International, Inc.2000-06-09
HI-RES 9000 PHASED ARRAY CAROTID COIL (K001210)Usa Instruments, Inc.2000-06-09
SYNERGY HEAD/NECK COIL (K001331)Philips Medical Systems North America, Inc.2000-06-09
AU5 ULTRASOUND IMAGING SYSTEM (K000931)Biosound Esaote, Inc.2000-06-08
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE (K994106)Olympus America, Inc.2000-06-02
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE (K994069)Olympus America, Inc.2000-06-02
PHARMASEED, MODEL BT-103-2 (K993700)Syncor International, Inc.2000-06-02
OPTIRAD (K993895)Permedics, Inc.2000-06-02
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM (K001336)Analogic Corp.2000-06-02
XPLORER 1000 (K992955)Imaging Dynamics Corp.2000-06-02
DR5000 DEDICATED CHEST X-RAY SYSTEM (K001341)Analogic Corp.2000-06-02
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) (K000976)Instrumentarium Imaging, Inc.2000-06-01
VFSS IMAGER, MODEL SIS-300 (K000987)Lifecare Imaging Intl., Ltd.2000-06-01
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS (K001201)Siemens Medical Solutions USA, Inc.2000-06-01
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL (K001209)Usa Instruments, Inc.2000-06-01
SPIRAL IMAGING OPTION (K000802)GE Medical Systems2000-05-26
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 (K000960)Barzell-Whitmore Maroon Bells, Inc.2000-05-26
OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT (K001203)The Olympus Optical Co.2000-05-26
IIVS INTEGRATED IMAGE VIEWING STATION (K994329)Terarecon,Inc.2000-05-26
LIBERTY 9000 BREAST COIL (K000993)Usa Instruments, Inc.2000-05-26
MODIFICATION TO ACCUDEXA BONE DENSITOMETER (K001429)Schick Technologies, Inc.2000-05-26
PROTON VISION (K000922)Varian Assoc., Inc.2000-05-24
ALL-PRO 2010 (K001321)All-Pro Imaging Corp.2000-05-16
PROVIEW MEDICAL IMAGE DISPLAY MODULE (K000770)Cerner Corp.2000-05-16
APOLLO MULTI-RACIAL REFERENCE POPULATION (K993337)Norland Medical Systems, Inc.2000-05-16
METRISCAN BONE DENSITY SYSTEM (K000162)Alara, Inc.2000-05-12
GE SYSTEM FIVE (K001267)Ge Medical Systems, Inc.2000-05-12
DELTA 16 TACT (K001171)Instrumentarium Imaging, Inc.2000-05-12
BALLOON FOR ULTRASONIC ENDOSCOPES (K992178)N.M. Beale Co., Inc.2000-05-12
PHILIPS CT SECURA MV (K000819)Philips Medical Systems North America, Inc.2000-05-12
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM (K000630)Hopkins Imaging Systems, Inc.2000-05-12
FOTOMASTER (K000380)Hamilton Thorne Research2000-05-03
AU5, AU6 (K000681)Biosound Esaote, Inc.2000-05-03
MOTORIZED MICRO MULTILEAF COLLIMATOR (K000349)Stryker Leibinger2000-05-03
IDS5 IMAGE DISPLAY SYSTEM (K001140)Sectra AB2000-05-03
EINSTEIN PROCESSING AND REVIEW WORKSTATION (K000395)Ge Medical Systems F.I. Haifa2000-05-03
SONOS AIRES 600 (SA-600) (K000320)Kpi Ultrasound, LLC2000-05-02
STEROTACTIC LOCALIZATION DEVICE (SLD) (K000832)Philips Medical Systems North America, Inc.2000-04-27
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE (K001006)Mds Nordion2000-04-27
GE LOGIQ 700 (K001016)GE Medical Systems2000-04-24
MEDVIZER PACS, MODEL RELEASE 2000 (K000557)Vitel Net2000-04-24
VISION R/F TILTING TABLE (K000412)Villa Sistemi Medicali S.P.A.2000-04-24
REMOTE FETAL MEDICINE ULTRASOUND SYSTEM (K000443)R4 Telemedicine, Inc.2000-04-24
OPART, MODEL MRT-600 (K000549)Toshiba America Mri, Inc.2000-04-20
PACSSTATION (K000448)Fernandez Industries, Inc.2000-04-20
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 (K000478)Accuray, Inc.2000-04-19
VIEW NT (K000474)Electromed Intl., Ltd.2000-04-19
GE LOGIQ 700 (K000516)Ge Medical Systems, Inc.2000-04-19
GE LOGIQ 700 (K000571)GE Medical Systems2000-04-18
ENHANCED COMPENSATING FILTER (K000137)Computerized Medical Systems, Inc.2000-04-17
CHILI VIDEO, CHILI VIDEOPRO (K000411)Steinbeis-Transferzentrum Medizinische Informatik2000-04-14
SONADA ULTRASOUND SYSTEM (K993092)Sonovision Corp.2000-04-14
INTERVENTIONAL BODY COIL (K000437)Usa Instruments, Inc.2000-04-14
PRODIGY LATERAL VIEW SOFTWARE (K000826)Lunar Corp.2000-04-14
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM (K000415)Optimal Imaging Systems, Inc.2000-04-11
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM (K000221)Ge Dec Medical Systems2000-04-11
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES (K000345)Medical Advances, Inc.2000-04-11
KFA-63 KNEE AND FOOT ARRAY (K000935)Mri Devices Corp.2000-04-07
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM (K993923)Adac Laboratories2000-04-07
SKYLIGHT IMAGING SYSTEM (K000908)Adac Laboratories2000-04-05
ISOSEED PD-103 (K993552)Bebig Isotopentechnik GmbH2000-03-31
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