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Radiology

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

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RecordFirmDate
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) (K014168)Biosound Esaote, Inc.2002-04-25
ISAAC 1.5 T MR SYSTEM (K020268)Chi, Inc.2002-04-25
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL (K020601)Odin Medical Technologies , Ltd.2002-04-24
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS (K020289)Machnet BV2002-04-24
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) (K020300)Syntermed, Inc.2002-04-23
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL (K020495)Surgi-Vision, Inc.2002-04-23
MOTION TRACKING (K020294)Accuray, Inc.2002-04-22
50S TRINGA ULTRASOUND IMAGING SYSTEM (K020112)Pie Medical2002-04-19
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM (K021049)Ge Oec Medical Systems2002-04-17
EFILM WORKSTATION WITH MODULES (K020995)Efilm Medical, Inc.2002-04-12
UD-1000 ULTRASONIC A/B SCANNER (K020151)Tomey Corp. USA2002-04-10
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 (K013848)U-Systems, Inc.2002-04-08
AL-2000 COMBINED BIOMETER AND PACHYMETER (K012803)Tomey Corp.2002-04-08
HDR MIAMI APPLICATOR (K020176)Mick Radio-Nuclear Instruments, Inc.2002-04-08
MEDICAL LE (K020058)Barco N.V.2002-04-04
ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS (K013088)Echotech 3D Imaging Systems, Inc.2002-04-04
GE VIVID 3 EXPERT; GE VIVID 3 PRO (K020789)General Electric Co.2002-04-04
CT-C3000 SPIRAL CT SCANNER SYSTEM (K020913)Neusoft Digital Medical Systems Co., Ltd.2002-04-03
SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 (K020929)GE Medical Systems2002-04-03
IMAGEDESK (K020061)Barco N.V.2002-04-03
MFCD 118I (K020059)Barco N.V.2002-04-03
CROSSPOINT TRANSACCESS CATHETER (K013363)Trans Vascular Incorporated2002-04-02
M3 (MIRCO-MULTILEAF COLLIMATOR (K004022)Brainlab AG2002-03-26
MOONRAY MOBILE C-ARM (K013426)Simad S.R.L.2002-03-26
CARD IQ ANALYSIS II (K020796)GE Medical Systems2002-03-26
PRONTO (K014240)Hitachi Medical Systems America, Inc.2002-03-22
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 (K020635)Eastman Kodak Company2002-03-21
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION (K020055)Philips Medical Systems2002-03-15
NVA-63-8 NEUROVASCULAR ARRAY COIL (K020606)Mri Devices Corp.2002-03-13
IMPLANT GUIDANCE SYSTEM APPLICATOR SET (K020015)Nucletron Corp.2002-03-13
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM (K020573)Siemens Medical Solutions USA, Inc.2002-03-13
PREFERNCE IMRT TREATMENT PLANNING MODULE (K012575)Northwest Medical Physics Equipment, Inc.2002-03-12
VIATRONIX V3D COLON (K020658)Viatronix, Inc.2002-03-07
LASERPRO 16 (K020243)Eradlink, Inc.2002-03-05
AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES (K014081)Aktina Medical Physics Corp.2002-03-05
SONOREAL 3D SYSTEM (K020068)Bio Medi Com2002-03-04
MRI LINE MARKER (K014022)I.Z.I. Corp.2002-03-04
NEUROSPECTQUAD GAMMA CAMERA (K013353)Nuclear Cardiology Systems, Inc.2002-03-04
KONICA DIRECT DIGITIZER REGIUS MODEL 350 (K013054)Konica Minolta Medical & Graphic, Inc.2002-03-01
ADVANTAGE WORKSTATION 4.1 (K020483)GE Medical Systems2002-02-28
WAVELENGHT ULTRASOUND LOTION (K013212)National Therapy Products, Inc.2002-02-25
PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 (K020436)Sedecal., Sa.2002-02-22
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS (K014033)Syntermed, Inc.2002-02-22
CP-SLEEVE (K013975)Cp Medical2002-02-22
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A (K020385)Toshiba America Medical Systems, In.C2002-02-15
OMNIA X/XS ULTRASOUND SYSTEM (K020353)Siemens Medical Systems, Inc.2002-02-13
ORION DIGITAL IMAGING SYSTEM (K012490)Infimed, Inc.2002-02-12
E-SCAN XQ (K020164)Biosound Esaote, Inc.2002-02-12
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER (K013722)Hitachi Medical Corp.2002-02-11
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER (K013723)Hitachi Medical Corp.2002-02-06
LOGIQ 3 (K020263)General Electric Co.2002-02-06
HANDHELD GAMMA FINDER (HGF) (K013751)Silicon Instruments Gmhb2002-02-06
DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM (K012439)Radco Data AB2002-02-06
MARK 5000 QUADRATURE SHOULDER COIL (K013854)Usa Instruments, Inc.2002-02-06
CANVAS N-VAS-D 2.0 (K014011)Vassol, Inc.2002-02-05
CTL BODY / SPINE ARRAY COIL (K014086)Usa Instruments, Inc.2002-02-05
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX (K013985)Machnet BV2002-02-01
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) (K013826)Siemens Medical Systems, Inc.2002-02-01
MODIFICATION TO VIEWSEND MEDICAL (K013994)Klt Telecom, Inc.2002-02-01
EXS-63 SMALL EXTREMITY ARRAY COIL (K020036)Mri Devices Corp.2002-02-01
HUMPHREY OCT3 (K012727)Carl Zeiss Ophthalmic Systems, Inc.2002-01-31
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM (K013922)Barco N.V.2002-01-28
VOXAR'S CALCIUM SCORING PRODUCT (K020140)Voxar Limited2002-01-28
BCC GAMMA CAMERA (K013667)Is2 Research, Inc.2002-01-28
HI-ART SYSTEM (K013673)Tomo Therapy, Inc.2002-01-28
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY (K013636)GE Medical Systems2002-01-24
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS (K013964)Cp Medical2002-01-24
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION (K013620)Medstone Intl., Inc.2002-01-22
BODY ARRAY COIL (K013594)Usa Instruments, Inc.2002-01-22
INFINION 0.6T MR IMAGING SYSTEM (K013858)Philips Medical Systems (Cleveland), Inc.2002-01-22
PREMIER III PHASED ARRAY CTL SPINE COIL (K013595)Usa Instruments, Inc.2002-01-22
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T (K013894)Philips Medical Systems North America, Inc.2002-01-18
EVTOOL MODEL # V. 1.0 (K013535)3D Line USA, Inc.2002-01-18
3DFIS, MODEL IES-FL-101 (K013841)3Dsharp, Inc.2002-01-17
KONICA LASER IMAGER, DRYPRO MODEL 751/752 (K013052)Konica Minolta Medical & Graphic, Inc.2002-01-16
LOGIQBOOK (K014206)General Electric Co.2002-01-16
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC (K013656)Planmed OY2002-01-16
ACCENT (K013574)Confirma, Inc.2002-01-15
BODYFIX (K013391)Medical Intelligence Medizintechnik GmbH2002-01-11
GE LOGIQ 5 (K014097)GE Medical Systems2002-01-10
EXTREMITY COIL (K013592)Usa Instruments, Inc.2002-01-08
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 (K014191)Philips Medical Systems2002-01-07
TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS (K014182)Tetrad Corp.2002-01-03
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL (K013514)Mri Devices Corp.2002-01-02
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (K003689)Canon USA, Inc.2002-01-02
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER (K013721)CIVCO Medical Instruments Co., Inc.2001-12-28
MAGNETOM TRIO SYSTEM (K013586)Siemens Medical Systems, Inc.2001-12-28
ENTEGRA PE PERSONAL DIGITAL ASSISTANT (K014058)General Electric Medical Systems2001-12-21
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II (K013218)Fujifilm Medical System U.S.A., Inc.2001-12-20
HAND-CARRIED ULTRASOUND SYSTEM (K014116)Sonosite,Inc.2001-12-20
CSIST DICOM GATEWAY/IMAGE MANAGER (K012327)Csist2001-12-20
NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM (K013419)Nicolet Biomedical2001-12-20
SHAPEABLE DOPPLER FLOW PROBE (K002958)Cook Vascular, Inc.2001-12-18
POLESTAR N-10 (K010850)Odin Medical Technologies , Ltd.2001-12-17
SHOULDER COIL (K013541)Usa Instruments, Inc.2001-12-14
CTS-415 (K013327)Shantou Institute of Ultrasonic Instuments2001-12-14
CRYSTAL 5000 PHASES ARRAY TMJ COIL (K013528)Usa Instruments, Inc.2001-12-13
INTERA I/T (K013344)Philips Medical Systems North America Co.2001-12-11
NURVO 9000 ENDOCAVITARY COILS (K011683)Usa Instruments, Inc.2001-12-10
VIATRONIC V3D CALCIUM SCORING (K013146)Viatronix, Inc.2001-12-07
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