meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
29
Latest Decision
2002-03-13

Clearances · page 91 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K020015 IMPLANT GUIDANCE SYSTEM APPLICATOR SET Nucletron Corp. JAQ Class II 2002-03-13
K020573 MODIFICATION TO MAGNETOM RHAPSODY SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 2002-03-13
K020606 NVA-63-8 NEUROVASCULAR ARRAY COIL Mri Devices Corp. MOS Class II 2002-03-13
K012575 PREFERNCE IMRT TREATMENT PLANNING MODULE Northwest Medical Physics Equipment, Inc. MUJ Class II 2002-03-12
K020658 VIATRONIX V3D COLON Viatronix, Inc. LLZ Class II 2002-03-07
K020243 LASERPRO 16 Eradlink, Inc. LMA Class II 2002-03-05
K014081 AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES Aktina Medical Physics Corp. IYE Class II 2002-03-05
K014022 MRI LINE MARKER I.Z.I. Corp. IYE Class II 2002-03-04
K020068 SONOREAL 3D SYSTEM Bio Medi Com IYO Class II 2002-03-04
K013353 NEUROSPECTQUAD GAMMA CAMERA Nuclear Cardiology Systems, Inc. KPS Class II 2002-03-04
K013054 KONICA DIRECT DIGITIZER REGIUS MODEL 350 Konica Minolta Medical & Graphic, Inc. MQB Class II 2002-03-01
K020483 ADVANTAGE WORKSTATION 4.1 GE Medical Systems LLZ Class II 2002-02-28
K013212 WAVELENGHT ULTRASOUND LOTION National Therapy Products, Inc. MUI Class II 2002-02-25
K013975 CP-SLEEVE Cp Medical KXK Class II 2002-02-22
K014033 EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS Syntermed, Inc. KPS Class II 2002-02-22
K020436 PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 Sedecal., Sa. IZL Class II 2002-02-22
K020385 CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A Toshiba America Medical Systems, In.C JAK Class II 2002-02-15
K020353 OMNIA X/XS ULTRASOUND SYSTEM Siemens Medical Systems, Inc. IYN Class II 2002-02-13
K012490 ORION DIGITAL IMAGING SYSTEM Infimed, Inc. OWB Class II 2002-02-12
K020164 E-SCAN XQ Biosound Esaote, Inc. LNH Class II 2002-02-12
K013722 MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Corp. IYN Class II 2002-02-11
K020263 LOGIQ 3 General Electric Co. IYN Class II 2002-02-06
K013854 MARK 5000 QUADRATURE SHOULDER COIL Usa Instruments, Inc. MOS Class II 2002-02-06
K013751 HANDHELD GAMMA FINDER (HGF) Silicon Instruments Gmhb IZD Class I 2002-02-06
K012439 DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM Radco Data AB LLZ Class II 2002-02-06
K013723 MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Corp. ITX Class II 2002-02-06
K014011 CANVAS N-VAS-D 2.0 Vassol, Inc. LNH Class II 2002-02-05
K014086 CTL BODY / SPINE ARRAY COIL Usa Instruments, Inc. MOS Class II 2002-02-05
K020036 EXS-63 SMALL EXTREMITY ARRAY COIL Mri Devices Corp. MOS Class II 2002-02-01
K013994 MODIFICATION TO VIEWSEND MEDICAL Klt Telecom, Inc. LLZ Class II 2002-02-01
K013985 MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX Machnet BV MOS Class II 2002-02-01
K013826 AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) Siemens Medical Systems, Inc. KPR Class II 2002-02-01
K012727 HUMPHREY OCT3 Carl Zeiss Ophthalmic Systems, Inc. IYO Class II 2002-01-31
K013673 HI-ART SYSTEM Tomo Therapy, Inc. MUJ Class II 2002-01-28
K013922 CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM Barco N.V. LLZ Class II 2002-01-28
K020140 VOXAR'S CALCIUM SCORING PRODUCT Voxar Limited LLZ Class II 2002-01-28
K013667 BCC GAMMA CAMERA Is2 Research, Inc. KPS Class II 2002-01-28
K013636 SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE Medical Systems LNH Class II 2002-01-24
K013964 MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS Cp Medical KXK Class II 2002-01-24
K013858 INFINION 0.6T MR IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 2002-01-22
K013620 MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION Medstone Intl., Inc. IZF Class II 2002-01-22
K013595 PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. MOS Class II 2002-01-22
K013594 BODY ARRAY COIL Usa Instruments, Inc. MOS Class II 2002-01-22
K013894 TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T Philips Medical Systems North America, Inc. MOS Class II 2002-01-18
K013535 EVTOOL MODEL # V. 1.0 3D Line USA, Inc. MUJ Class II 2002-01-18
K013841 3DFIS, MODEL IES-FL-101 3Dsharp, Inc. LLZ Class II 2002-01-17
K013656 PLANMED SOPHIE & PLANMED SOPHIE CLASSIC Planmed OY IZH Class II 2002-01-16
K013052 KONICA LASER IMAGER, DRYPRO MODEL 751/752 Konica Minolta Medical & Graphic, Inc. LMC Class II 2002-01-16
K014206 LOGIQBOOK General Electric Co. IYO Class II 2002-01-16
K013574 ACCENT Confirma, Inc. LLZ Class II 2002-01-15
K013391 BODYFIX Medical Intelligence Medizintechnik GmbH IYE Class II 2002-01-11
K014097 GE LOGIQ 5 GE Medical Systems IYN Class II 2002-01-10
K013592 EXTREMITY COIL Usa Instruments, Inc. MOS Class II 2002-01-08
K014191 M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 Philips Medical Systems IYN Class II 2002-01-07
K014182 TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS Tetrad Corp. ITX Class II 2002-01-03
K013514 PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL Mri Devices Corp. MOS Class II 2002-01-02
K003689 CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 Canon USA, Inc. IXK Class II 2002-01-02
K013721 SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO Medical Instruments Co., Inc. ITX Class II 2001-12-28
K013586 MAGNETOM TRIO SYSTEM Siemens Medical Systems, Inc. LNH Class II 2001-12-28
K014058 ENTEGRA PE PERSONAL DIGITAL ASSISTANT General Electric Medical Systems LLZ Class II 2001-12-21
K013218 FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II Fujifilm Medical System U.S.A., Inc. MQB Class II 2001-12-20
K012327 CSIST DICOM GATEWAY/IMAGE MANAGER Csist LLZ Class II 2001-12-20
K013419 NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM Nicolet Biomedical LLZ Class II 2001-12-20
K014116 HAND-CARRIED ULTRASOUND SYSTEM Sonosite,Inc. IYN Class II 2001-12-20
K002958 SHAPEABLE DOPPLER FLOW PROBE Cook Vascular, Inc. ITX Class II 2001-12-18
K010850 POLESTAR N-10 Odin Medical Technologies , Ltd. LNH Class II 2001-12-17
K013327 CTS-415 Shantou Institute of Ultrasonic Instuments IYO Class II 2001-12-14
K013541 SHOULDER COIL Usa Instruments, Inc. MOS Class II 2001-12-14
K013528 CRYSTAL 5000 PHASES ARRAY TMJ COIL Usa Instruments, Inc. MOS Class II 2001-12-13
K013344 INTERA I/T Philips Medical Systems North America Co. LNH Class II 2001-12-11
K011683 NURVO 9000 ENDOCAVITARY COILS Usa Instruments, Inc. MOS Class II 2001-12-10
K013146 VIATRONIC V3D CALCIUM SCORING Viatronix, Inc. JAK Class II 2001-12-07
K013036 NOMOS MOTORIZED CRANE II Nomos Corp. JAI Class II 2001-12-07
K013098 KIMAX REMOTE VIEWING STATION Medical Metrics, Inc. LLZ Class II 2001-12-07
K013686 KODAK DIRECTVIEW TABLETOP CASSETTE Eastman Kodak Company IXA Class II 2001-12-07
K013878 CYBERMED, INC., V-WORKS Cybermed, Inc. LLZ Class II 2001-12-07
K013112 FOCAL SIM Computerized Medical Systems, Inc. MUJ Class II 2001-12-05
K013630 ISITE RADIOLOGY Stentor, Inc. LLZ Class II 2001-12-05
K013660 GENETRA Radiomed Corporation KXK Class II 2001-12-05
K011845 MILLCOMP Math Resolutions, LLC IYE Class II 2001-12-04
K002113 CTXA HIP; CTXA; QCT PRO CTXA HIP Mindways Software, Inc. KGI Class II 2001-12-04
K013661 XPLAN 2.2 WITH THE BODY SYSTEM Radionics, A Division of Tyco Healthcare Group LP MUJ Class II 2001-12-03
K013849 TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS Tetrad Corp. ITX Class II 2001-12-03
K010166 IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM Imagyn Medical Technologies, Inc. IWJ Class I 2001-12-03
K012953 GIOTTO IMAGE Medx, Inc. IZH Class II 2001-11-30
K012941 DRYSTAR, MODEL 4500M Agfa Corp. LMC Class II 2001-11-29
K013810 CARDIOVASCULAR ARRAY W. L. Gore & Associates, Inc. MOS Class II 2001-11-27
K013631 EFILM VIDEO Efilm Medical, Inc. LMA Class II 2001-11-20
K013602 HNC-63-INT NEUROVASCULAR ARRAY COIL Mri Devices Corp. MOS Class II 2001-11-20
K012875 SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM GE Medical Systems LNH Class II 2001-11-20
K013508 HRH-127-ALLEGRA HEAD ARRAY COIL Mri Devices Corp. MOS Class II 2001-11-20
K013627 SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. IYN Class II 2001-11-16
K013608 DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D Toshiba America Medical Systems, In.C OWB Class II 2001-11-15
K012750 ADC PEDIATRIC Agfa Corp. MQB Class II 2001-11-14
K013291 ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) Advanced Diagnostics, Inc. NCS Class II 2001-11-14
K013170 SCANTAC MEMBRANE OR SCANTAC STRIP Sonotech, Inc. ITX Class II 2001-11-13
K013633 SSA-770A, APLIO ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C IYO Class II 2001-11-13
K013548 STANDARD IMAGING IVB 1000 WELL CHAMBER Standard Imaging, Inc. KPT Class II 2001-11-09
K011196 IQUANTIFY, VERSION 1.0 Insightful Corporation LLZ Class II 2001-11-08
K013561 LIGHTSPEED 4.0 CT SCANNER SYSTEM GE Medical Systems JAK Class II 2001-11-08

14,721 clearances in the Radiology panel. Data: openFDA.