meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
31
Latest Decision
1996-12-06

Clearances · page 107 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K963624 PHILIPS SLI SERIES LINEAR ACCELERATOR Philips Medical Systems, Inc. IYE Class II 1996-12-06
K963705 COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A Toshiba America Medical Systems, In.C IYN Class II 1996-12-02
K953233 SIMVIEW 3000 CT OPTION Siemens Medical Solutions USA, Inc. KPQ Class II 1996-11-29
K963697 ADVANCED DIAGNOSTIC VIEWER (ADV) Bio-Vascular, Inc. LLZ Class II 1996-11-27
K962061 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems LNH Class II 1996-11-27
K963941 THE PHARAOH COMPENSATING FILTER Octostop, Inc. KPR Class II 1996-11-27
K963429 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems LNH Class II 1996-11-27
K963610 AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES A.L.I. Technologies, Inc. LLZ Class II 1996-11-27
K962481 QUASAR RECOVERY IMAGING PACKAGE Trionix Research Laboratory, Inc. KPS Class II 1996-11-27
K963356 PHASED ARRAY SHOULDER COIL Philips Medical Systems (Cleveland), Inc. MOS Class II 1996-11-22
K963363 HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS Hologic, Inc. KGI Class II 1996-11-22
K963258 PEACOCK SYSTEM Nomos Corp. IYE Class II 1996-11-18
K961740 KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT Kodak Health Imaging Systems, Inc. LLZ Class II 1996-11-14
K961739 KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT Kodak Health Imaging Systems, Inc. LLZ Class II 1996-11-14
K963186 ORTHO 8000 Inner Vision Mri , Ltd. LNH Class II 1996-11-12
K962792 LINAC SCALPEL TREATMENT PLANNING SYSTEM Surgical Navigation Technologies, Inc. IYE Class II 1996-11-12
K963905 RADIOGRAPHIC ITT TABLE X-Ray Technologies, Inc. KXJ Class II 1996-11-12
K963169 RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL Rapid-Aid Ltd./Ltee ITX Class II 1996-11-12
K964266 BIAD NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1996-11-12
K964265 CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1996-11-12
K964267 MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1996-11-12
K964268 TRIAD 88 NUCLEAR IMAGING SYSTEM Trionix Research Laboratory, Inc. KPS Class II 1996-11-12
K963162 QUANTEM Elscint, Inc. KPS Class II 1996-11-12
K954679 THERAPLAN PLUS Theratronics, Inc. IYE Class II 1996-11-08
K962364 CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) Codonics, Inc. LMC Class II 1996-11-08
K963617 SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120 Shimadzu Medical Systems JAA Class II 1996-11-08
K963592 IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000 Dejarnette Research Systems LMD Class I 1996-11-07
K961484 CASS SYSTEM (MODIFICATION) Medical Instrumentation & Diagnostics Corp.(Midco) IYE Class II 1996-11-07
K963179 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems LNH Class II 1996-11-07
K963594 IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) Dejarnette Research Systems LMD Class I 1996-11-07
K963893 FIBRE INTERSPACED X-RAY GRID Smit Rontgen IXJ Class I 1996-11-07
K964263 EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE Lunar Corp. KGI Class II 1996-11-07
K963628 IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE Dejarnette Research Systems LMD Class I 1996-11-07
K963274 V-LINK 3.2 FOR WINDOWS Koven Technology, Inc. IYO Class II 1996-10-31
K962892 HELAX TMS BRACHYTHERAPY, VERSION 3.0 Siemens Medical Solutions USA, Inc. LNH Class II 1996-10-29
K961833 SONOLINE ELEGRA WITH SIESCAPE FEATURE Siemens Medical Solutions USA, Inc. IYO Class II 1996-10-29
K962955 GAMMACON IMAGE TRANSLATION SYSTEM Medical Imaging Technology Assoc., Inc. KPS Class II 1996-10-28
K962967 FUJI MEDICAL DRY IMAGER FM-DP 2636 Fujifilm Medical System U.S.A., Inc. LMC Class II 1996-10-28
K962225 VIEWSEND MEDICAL MODEL 1200 Klt Telecom, Inc. LMD Class I 1996-10-25
K963395 IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM Sectra-Imtec AB LMB Class I 1996-10-25
K962933 OPART MRT-600 Toshiba America Mri, Inc. LNH Class II 1996-10-25
K960985 SLS-CT Bio-Imaging Research, Inc. JAK Class II 1996-10-25
K951567 CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE Cardio Metrics, Inc. ITX Class II 1996-10-25
K963345 ADVANTAGE WINDOWS TISSUE VOLUME OPTION GE Medical Systems LNH Class II 1996-10-18
K961624 FLEXART TMJ COIL Toshiba America Mri, Inc. LNH Class II 1996-10-18
K962797 ECAT EXACT & ECAT EXACT HR+ Cti Pet Systems, Inc. KPS Class II 1996-10-15
K962738 MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS GE Medical Systems KPS Class II 1996-10-10
K962622 INTRA-ORAL THERMOPLASTIC SHIELD Medtec, Inc. KPY Class I 1996-10-01
K963585 BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 Diagnostic Ultrasound Corp. IYO Class II 1996-10-01
K962613 DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM Gulmay Medical , Ltd. JAD Class II 1996-09-27
K963037 PATRIOT Infimed, Inc. LLZ Class II 1996-09-27
K962927 IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS Siemens Medical Solutions USA, Inc. LNH Class II 1996-09-25
K962896 KODAK DIGITAL SCIENCE REMOTE CASSETTE Eastman Kodak Company KPR Class II 1996-09-20
K960865 STEP OPTION TO PRISM 2000 Philips Medical Systems (Cleveland), Inc. KPS Class II 1996-09-20
K961140 FLUOROPLUS CARDIAC TV Cmt Medical Technologies, Ltd. JAA Class II 1996-09-20
K962677 ESTEEM 1.5T MRI SYSTEM Elscint Mr, Inc. LNH Class II 1996-09-20
K962589 AURORA DIAGNOSTIC WORKSTATION Aurora Technology, Inc. LLZ Class II 1996-09-20
K962293 ENDOSONICS AUTOMATIC PULL BACK DEVICE Endosonics Corp. ITX Class II 1996-09-16
K962319 NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES Neoprobe Corp. IZD Class I 1996-09-13
K960192 POSITRON COINCIDENCE DETECTION Philips Medical Systems (Cleveland), Inc. KPS Class II 1996-09-12
K963334 JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 Jamieson Film Co. IXX Class II 1996-09-11
K962260 REAL-TIME VIDEO CONTRAST ENHANCER Digivision, Inc. LLZ Class II 1996-09-09
K961023 AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) Accuimage, Inc. LMD Class I 1996-09-09
K953974 CAMVISION 1000 Medivision Medical Imaging, Ltd. JAA Class II 1996-09-09
K962487 BREAST TREATMENT AID M200 S. and H. Engineering, Inc. IYE Class II 1996-09-09
K961628 MINI FLEX COIL W. L. Gore & Associates, Inc. MOS Class II 1996-09-05
K961105 SKIN DOSE MONITOR Mcmahon Medical OWB Class II 1996-09-05
K961969 HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE Hitachi Medical Systems America, Inc. LNH Class II 1996-09-05
K961525 ARRAY OPEN BREAST COIL (MODEL OBC-63 PA) Mri Devices Corp. MOS Class II 1996-09-05
K961597 GATED MIBI 3-D EJECTION FRACTION PROCESSING Trionix Research Laboratory, Inc. KPS Class II 1996-09-04
K962618 GYREX V-EP Elscint, Inc. LNH Class II 1996-09-04
K963093 SIREMOBIL COMPACT Siemens Medical Solutions USA, Inc. OXO Class II 1996-09-03
K960700 LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems IYO Class II 1996-08-28
K962117 QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS Philips Medical Systems (Cleveland), Inc. LNH Class II 1996-08-27
K962080 RPS-50 BEAM SCANNER Sofield Science Services, Inc. IYE Class II 1996-08-23
K962051 ASPECT OPTICAM Aspect Electronics, Inc. LMC Class II 1996-08-23
K961768 KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) Kodak Health Imaging Systems, Inc. LMA Class II 1996-08-22
K961692 SONOSCAN Sonotech, Inc. ITX Class II 1996-08-22
K962155 GILL-THOMAS-COSMAN(GTC) DENTAL TRAY Radionics Software Applications, Inc. IYE Class II 1996-08-22
K951052 WEEKS APPLICATOR Duke University Medical Center IWJ Class I 1996-08-22
K962750 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR Imation Corp. IXW Class II 1996-08-21
K961849 THE ROBOGUIDE Shai Syg Motion and Innovations, Ltd. IZH Class II 1996-08-21
K961207 EP-X BIPLANE Fischer Imaging Corp. JAA Class II 1996-08-20
K962699 RADWORKS MEDICAL IMAGING SOFTWARE Applicare Medical Imaging, B.V. LMD Class I 1996-08-19
K961374 PHILIPS MULTIDIAGNOST 4 Philips Medical Systems, Inc. OWB Class II 1996-08-19
K962048 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) Hitachi Medical Systems America, Inc. LNH Class II 1996-08-14
K961983 TRS 2000 TELERADIOLOGY SYSTEM Sectra-Imtec AB LLZ Class II 1996-08-13
K953946 MICROSELECTRON-HDR VERSION 2 Nucletron-Oldelft Corp. JAQ Class II 1996-08-13
K961467 HEAD RETAINING DEVICE S. and H. Engineering, Inc. IYE Class II 1996-08-09
K960765 MENTOR ADVENT A/B SYSTEM Mentor Ophthalmics, Inc. IYO Class II 1996-08-08
K961116 FIRST BEAT/CARDIO BEAT/CALC Medasonics, Inc. IYO Class II 1996-08-08
K961902 SIEMENS BEAM SHAPER Siemens Medical Solutions USA, Inc. IXI Class II 1996-08-08
K954028 HP SONOS ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. IYN Class II 1996-08-08
K962606 TOPOGRAPHIC IMAGING MARKER I.Z.I. Medical Products Corp. JAA Class II 1996-08-07
K961214 MULTI LEAF COLLIMATOR Mitsubishi Intl. Corp. IYE Class II 1996-08-06
K954861 BRAINLAB CT/X-RAY LOCALIZER Brainlab Med. Computersysteme GmbH IYE Class II 1996-08-05
K961842 SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM Toshiba America Mri, Inc. LNH Class II 1996-08-02
K960044 ULTRAMAX/MODEL NUMBER A1 Entlab OY LWI Class II 1996-08-02
K960293 MRTOFLM COMPUTER PROGRAM Northwest Medical Physics Equipment, Inc. IYE Class II 1996-08-01
K961871 FLOUROSPOT T.O.P. Siemens Medical Solutions USA, Inc. LLZ Class II 1996-07-31

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