meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
38
Latest Decision
1995-11-24

Clearances · page 110 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K952684 VERTEX EPIC MCD Adac Laboratories KPS Class II 1995-11-24
K942604 SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM GE Medical Systems LNH Class II 1995-11-24
K952564 INSPECT/PROSPECT Adac Laboratories KPS Class II 1995-11-22
K953801 VARICAM Elscint, Inc. KPS Class II 1995-11-22
K952913 APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER Varian Assoc., Inc. JAQ Class II 1995-11-22
K953292 CP 100/30 Micro-Focus Imaging., Inc. IZL Class II 1995-11-22
K950630 WALLACH DIGITAL IMAGING SYSTEM Wallach Surgical Devices, Inc. LMB Class I 1995-11-22
K953227 CASPER Northwest Medical Physics Center IXI Class II 1995-11-22
K954668 HP ECHO IMAGE MANAGEMENT SYSTEM Hewlett-Packard Co. LLZ Class II 1995-11-22
K943200 FLOSCOPE SUPER VASCULAR LAB Advance Medical Device, Inc. JAF Class II 1995-11-21
K945072 SIEMENS Q4000 Siemens Medical Solutions USA, Inc. IYN Class II 1995-11-21
K924849 LEKSELL GAMMA UNIT MODEL 23004,TYPE B. Elekta Radiosurgery, Inc. IWB Class II 1995-11-20
K954190 MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL Medical Advances, Inc. MOS Class II 1995-11-20
K954590 MAX-1000A/R1 Toshiba America Medical Systems, In.C JAA Class II 1995-11-20
K945400 HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 Hitachi Medical Corp. of America IZI Class II 1995-11-20
K953095 PHILIPS EASYVISION Philips Medical Systems, Inc. LLZ Class II 1995-11-14
K954225 MED-TEC HAND GRIP Medtec, Inc. IXQ Class II 1995-11-14
K951723 GE B510 TRANSDUCER GE Medical Systems ITX Class II 1995-11-14
K951650 CLINICAL PROTON SPECTROSCOPY OPTION Siemens Medical Solutions USA, Inc. LNH Class II 1995-11-14
K940001 PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) Nucletron Corp. IYE Class II 1995-11-14
K954355 ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION General Electric Co. LNH Class II 1995-11-14
K954149 ASPECT DIGITAL FORMATTER Aspect Electronics, Inc. LMC Class II 1995-11-13
K953894 SIEMENS MULTILEAF COLLIMATOR Siemens Medical Solutions USA, Inc. IXI Class II 1995-11-13
K950513 ARCHIVEMANAGER Cemax, Inc. LMD Class I 1995-11-13
K951830 ADVANTAGE SIM General Electric Co. KPQ Class II 1995-11-13
K951262 OPERATING ARM SYSTEM (OAS) Radionics Software Applications, Inc. LLZ Class II 1995-11-13
K951681 QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER Fonar Corp. LNH Class II 1995-11-09
K955094 EXAMINATION PAD Inventive Products, Inc. IYO Class II 1995-11-09
K942243 IMEX 8000 PERSONAL CASCULAR LAB Imex Medical Systems, Inc. IYO Class II 1995-11-03
K953513 XENON CIRCUIT King Systems Corp. IYT Class II 1995-11-03
K953595 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE Medical Systems MOS Class II 1995-10-27
K951373 FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ Fujifilm Medical System U.S.A., Inc. IXW Class II 1995-10-27
K954008 REDI-VU SYSTEMS (SEND & RECEIVE) Jd Technical Services, Inc. LMD Class I 1995-10-27
K945795 EUB-555A+ Hitachi Medical Corp. of America IYO Class II 1995-10-27
K936067 ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM Atlantis Diagnostics Intl., Inc. IYN Class II 1995-10-27
K945838 CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY Toshiba America Medical Systems, In.C KPQ Class II 1995-10-25
K953482 XKNIFE-3 Radionics Software Applications, Inc. IYE Class II 1995-10-25
K953570 PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP) Philips Medical Systems, Inc. IYE Class II 1995-10-25
K954521 MAMMOSPOT PADDLE American Mammographics, Inc. IZH Class II 1995-10-24
K953552 SIENET SPI SPOOLER Siemens Medical Solutions USA, Inc. LMD Class I 1995-10-24
K953193 SCINTRON IV Medical Imaging Electronics America, Inc. KPS Class II 1995-10-24
K954196 UNIVERSIX 120 Philips Medical Systems (Cleveland), Inc. KPR Class II 1995-10-24
K953255 NUQUEST NUCLEAR MEDICINE COMPUTER Sitco, Inc. KPS Class II 1995-10-24
K953430 ULTRASOUND PROBE BIOPSY ACCESSORIES Biosound, Inc. ITX Class II 1995-10-24
K954055 HDX DIGITAL IMAGING SYSTEM Imacom, Inc. LLZ Class II 1995-10-24
K953032 LUNAR DPX DENSITOMETER Lunar Corp. KGI Class II 1995-10-23
K953248 IRIS BILATERAL TMJ Hitachi Medical Systems America, Inc. LNH Class II 1995-10-23
K954414 CENTRALITE BACKPOINTER Diacor, Inc. IWE Class I 1995-10-23
K935454 DPX TISSUE QUANTIFICATION OUTPUT Lunar Corp. JAK Class II 1995-10-19
K954310 BLA-800A Toshiba Medical Systems KPW Class II 1995-10-18
K954484 KODAK AUTOMIXER II PLUS Eastman Kodak Company IXW Class II 1995-10-18
K953910 PHILIPS BV 300 SERIES Philips Medical Systems North America, Inc. OXO Class II 1995-10-18
K945983 BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS Bebig Trade, Inc. KXK Class II 1995-10-18
K953371 LUMISYS DICOM TOOKLIT Lumisys, Inc. LMD Class I 1995-10-18
K954345 DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR Doosan Corp. IXW Class II 1995-10-18
K953468 SONOGEL Sonotech, Inc. IYO Class II 1995-10-17
K953262 QD BILATERAL BREAST COIL Hitachi Medical Systems America, Inc. LNH Class II 1995-10-17
K954356 COMPAX 90/15E General Electric Co. IXR Class II 1995-10-07
K951764 UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR Ptw-New York Corp. IYE Class II 1995-10-07
K953475 CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING The DU Pont Co. LMC Class II 1995-10-07
K953477 MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING The DU Pont Co. LMC Class II 1995-10-07
K953514 COURIER II Gammex, Inc. LMD Class I 1995-10-07
K954255 PHILIPS TOMOSCAN SR 8000 Philips Medical Systems North America, Inc. JAK Class II 1995-10-07
K945517 MAGNETOM VISION (PROJECT 016) Siemens Medical Solutions USA, Inc. LNH Class II 1995-10-07
K943440 PROFILE 7000 C-SPINE COIL Us Asia Instruments, Inc. LNH Class II 1995-10-06
K953398 UNISCAN Merlin Engineering Works, Inc. LMD Class I 1995-10-06
K954309 ANGIOREX Toshiba Medical Systems IZI Class II 1995-10-06
K953563 VANGUARD XR-350 CINEANGIOGRAM PROJECTOR Jamieson Film Co. IZI Class II 1995-10-05
K946179 SIEMENS SONOLINE 4XX Siemens Medical Solutions USA, Inc. IYO Class II 1995-10-03
K954198 VOXCAM Voxel LMC Class II 1995-09-29
K953246 OCTOROLL Octostop, Inc. KXH Class I 1995-09-29
K954200 VOXGRAM Voxel IWZ Class I 1995-09-29
K954199 VOXBOX Voxel IXC Class I 1995-09-29
K953080 DIGITAL IMAGING SYSTEM INTERFACE Camtronics, Ltd. LMD Class I 1995-09-28
K953582 HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR Varian Canada, Inc. IZO Class I 1995-09-26
K953610 AUKULYTE Aukland Medical Plastics, Inc. KPY Class I 1995-09-26
K953556 VACS TABLE, 9650 U.S. Imaging Tables, Inc. IXR Class II 1995-09-26
K952674 TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA Elscint, Inc. KPS Class II 1995-09-26
K953557 SURGICAL C-ARM TABLE, 9610 U.S. Imaging Tables, Inc. IXR Class II 1995-09-26
K953163 QUICK READ 2000 (QR2000) Quicksilver Systems, Inc. LMD Class I 1995-09-22
K953046 PERI-PUSHER Diacor, Inc. IYE Class II 1995-09-22
K950276 MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM Endosonics Corp. IYO Class II 1995-09-22
K952862 FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR Fujifilm Medical System U.S.A., Inc. LLZ Class II 1995-09-20
K945791 GYRES 2T PRESTIGE Elscint, Inc. LNH Class II 1995-09-19
K945827 OUTLOOK Philips Medical Systems (Cleveland), Inc. LNH Class II 1995-09-18
K941935 LP-12 LAPAROSCOPIC PROBE Biosound, Inc. ITX Class II 1995-09-18
K953964 LUMISYS, LUMISCAN 20 Lumisys, Inc. LMA Class II 1995-09-18
K952888 OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS Olympus America, Inc. LMB Class I 1995-09-18
K953950 FLUORO CATHETER Cmt Medical Technologies, Ltd. JAA Class II 1995-09-18
K952914 STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM Star Technologies, Inc. LMD Class I 1995-09-18
K952729 PAINTED WEDGE & ROD BREAST BOARD Medtec, Inc. IYE Class II 1995-09-15
K950279 TOMTECP90 Tomtec Imaging Systems, Inc. LMB Class I 1995-09-15
K951807 KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER Kodak Health Imaging Systems, Inc. LMC Class II 1995-09-13
K951948 KODAK XLS 8600 (PS) Kodak Health Imaging Systems, Inc. LMC Class II 1995-09-13
K953918 MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc. LNH Class II 1995-09-12
K953832 SOLARIX FV GE Medical Systems KPR Class II 1995-09-12
K953831 N 800 HF Nucletron-Oldelft Corp. IZO Class I 1995-09-08
K953725 CRONEX RADIATION THERAPY VERIFICATION CASSETTE E.I. Dupont DE Nemours & Co., Inc. IXA Class II 1995-09-06
K952778 CHESHIRE Perceptive Systems, Inc. LLZ Class II 1995-09-06
K953724 CRONEX RADIATION THERAPY CASSETTE E.I. Dupont DE Nemours & Co., Inc. IXA Class II 1995-09-06

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