meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
30
Latest Decision
1995-09-06

Clearances · page 111 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K950359 KONICA LASER IMAGER LI-21 Storch Amini & Munves PC LMC Class II 1995-09-06
K941362 BONE MINERAL DENSITOMETER Hologic, Inc. KGI Class II 1995-08-30
K944724 HEALTH IMAGE INC. HI STAR Health Images, Inc. LNH Class II 1995-08-30
K941118 HEAD IMMOBILIZATION APPARATUS Northwest Medical Physics Center IYE Class II 1995-08-25
K952944 MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL Medical Advances, Inc. MOS Class II 1995-08-23
K952457 RAPID-FOAM The Soule Co., Inc. IYE Class II 1995-08-23
K952533 SIENET DICOM GATEWAY Siemens AG LMD Class I 1995-08-23
K952109 IP500 NUCLEAR GAMMA CAMERA SYSTEM Siemens Medical Solutions USA, Inc. KPS Class II 1995-08-23
K945779 MAGNETOM VISION (PROJECT 016) Siemens Medical Solutions USA, Inc. LNH Class II 1995-08-23
K936024 ULTRASOUND SCANNER 2001 B & K Medical A/S IYO Class II 1995-08-22
K950293 TEC-2110 GREEN LASER MODEL MT-HNG Medtec, Inc. IWE Class I 1995-08-18
K950112 CENTRALITE(R)-DLL SERIES Diacor, Inc. IWE Class I 1995-08-16
K952313 VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION Varian Assoc., Inc. LLZ Class II 1995-08-16
K950061 HERCULES RADIATION THERAPY COUCH Precision Therapy Intl., Inc. IYE Class II 1995-08-16
K952223 XENON GAS BREATHING CIRCUIT Intertech Resources, Inc. IYT Class II 1995-08-11
K953336 VRS 3 WALL STAND Philips Medical Systems (Cleveland), Inc. IXY Class I 1995-08-11
K953402 UNIVERSIX 190 Philips Medical Systems (Cleveland), Inc. IXY Class I 1995-08-11
K953164 ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION Toshiba America Medical Systems, In.C LLZ Class II 1995-08-09
K943189 MEDRAD QWIK-FIX MRI DISPOSABLE KIT Medrad, Inc. LNH Class II 1995-08-09
K952189 MED-TEC REDISET Medtec, Inc. IYE Class II 1995-08-09
K945730 SIGNA PROFILE GE Medical Systems LNH Class II 1995-08-09
K945773 SIEMENS SONOLINE VERSA Siemens Medical Solutions USA, Inc. IYN Class II 1995-08-07
K945807 HOMEVUE WOUND MONITORING SYSTEM Homevue Health Systems, Inc. LLZ Class II 1995-08-07
K953444 MCI OPTONIX ECONOMY CASSETTE Mci Optonix, Inc. IXA Class II 1995-08-02
K945188 CEMAX VIPSTATION AND/OR SOFTWARE Cemax, Inc. LLZ Class II 1995-08-02
K941322 ECHO-SCAN Tomographic Tech IYO Class II 1995-07-27
K946300 DOPPLEX SURGICAL PROBES Hne Healthcare, Inc. ITX Class II 1995-07-26
K950966 MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE Medical Advances, Inc. MOS Class II 1995-07-26
K952210 LORAD STEROLOC II Lorad Corp. IZH Class II 1995-07-24
K952530 HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE Philips Medical Systems (Cleveland), Inc. LNH Class II 1995-07-24
K944040 PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM S & S X-Ray Products, Inc. IYE Class II 1995-07-21
K944228 HEALTH IMAGES, INC. HI-STANDARD Health Images, Inc. LNH Class II 1995-07-20
K952871 RIDGES PLUS Octostop, Inc. KPR Class II 1995-07-20
K952672 VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM Bennett X-Ray Corp. KPR Class II 1995-07-13
K952891 CRONEX LOW ABSORPTION CASSETTE The DU Pont Co. IXA Class II 1995-07-13
K950075 MED-TEC TRAY ADAPTER Medtec, Inc. IYE Class II 1995-07-13
K951947 MED-TEC RADIO THERAPY TREATMENT CHAIR Medtec, Inc. IYE Class II 1995-07-12
K952822 SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G Shimadzu Corp. IZO Class I 1995-07-12
K951679 MED-TEC TESTICULAR SEPARATOR Medtec, Inc. IYE Class II 1995-07-12
K951925 DICOMIT Dicomit Imaging Systems Corp. IYO Class II 1995-07-12
K945321 WELLHOFER WP700 V. 3.2 Medical Physics Instrumentation, Inc. IYE Class II 1995-07-12
K951808 MED-TEC REDI-FOAM Medtec, Inc. IYE Class II 1995-07-06
K952265 MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR Control-X, Inc. IZO Class I 1995-07-06
K952701 MED-TRON SPECT IMAGING TABLE Med-Tron Products, Inc. IZZ Class II 1995-07-06
K951144 PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS GE Medical Systems KPS Class II 1995-07-03
K952704 PHILIPS EASYVISION Philips Medical Systems, Inc. IZI Class II 1995-07-03
K950413 MEDIPACS Nexsys Electronics LMD Class I 1995-06-30
K951175 MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS) Sirius Corp. LMD Class I 1995-06-30
K941566 COMPUSPEAK Hogan & Hartson LLZ Class II 1995-06-30
K945540 CAAS II Pie Medical Equipment B.V. IZI Class II 1995-06-28
K951717 MED-TEC KNEE CRUTCH Medtec, Inc. IYE Class II 1995-06-28
K952232 MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 Medrad, Inc. LNH Class II 1995-06-26
K952235 MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15 Medrad, Inc. LNH Class II 1995-06-26
K952484 MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A Toshiba America Medical Systems, In.C LMD Class I 1995-06-23
K951649 MODEL #801GE1500 PEDIATRIC ARRAY COIL Medic, Inc. LNH Class II 1995-06-22
K952493 FLUORECORD MODEL 762 Syracuse Scientific, Inc. JAA Class II 1995-06-22
K944597 GRAHAM-FIELD ULTRASOUND SCANNING GEL Chester Labs, Inc. IYO Class II 1995-06-21
K926363 MULTI-DOP S Dantec Medical, Inc. IYO Class II 1995-06-19
K944070 ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING Advanced Nmr Systems, Inc. LNH Class II 1995-06-19
K941666 SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS General Electric Co. LNH Class II 1995-06-19
K951143 PULSE KLYSTRON AMPLIFIFER (L-5822-90) Litton Systems, Inc. IYE Class II 1995-06-19
K951145 VMI 1000 SURGICAL PACEOMETER Vision Medical Instruments, Inc. ITX Class II 1995-06-19
K945582 WITT BIOMEDICAL IMAGE III Witt Biomedical Corporation LLZ Class II 1995-06-19
K945515 COATED TUNGSTEN EYESHIELD Medtec, Inc. IWS Class I 1995-06-19
K952233 CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 Victoreen, Inc. EAK Class I 1995-06-16
K951142 PULSE KLYSTRON AMPLIFIER (L-5822-00) Litton Systems, Inc. IYE Class II 1995-06-16
K952456 IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM Fisher Imaging Corp. JAA Class II 1995-06-16
K931801 MULTI-DOP X Dantec Medical, Inc. IYO Class II 1995-06-14
K944017 OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM Olympus America, Inc. ITX Class II 1995-06-13
K944979 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE Medical Systems LNH Class II 1995-06-13
K935615 MEDICAL LINEAR ACCELERATOR Accelerator Systems Intl., Inc. IYE Class II 1995-06-09
K946085 THIN-FILM CARDIAC GATING CABLE General Electric Co. LNH Class II 1995-06-05
K952060 QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 Image Analysis, Inc. KGI Class II 1995-06-05
K945903 BRAINLAB MASK SYSTEM Brainlab Med. Computersysteme GmbH IYE Class II 1995-06-05
K950781 COMPACT 7600 Ge Dec Medical Systems JAA Class II 1995-06-05
K944287 7050 ULTRASOUND IMAGING SYSTEM Biosound, Inc. ITX Class II 1995-06-02
K951141 STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER Star Technologies, Inc. LMB Class I 1995-05-30
K942558 INSTACINE Fidelity Medical, Inc. LMB Class I 1995-05-30
K952188 ADVIEWER 2000 Adp , Ltd. IXC Class I 1995-05-30
K950866 HIP FIXATION SYSTEM Medtec, Inc. IYE Class II 1995-05-30
K951883 PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT Planmed OY IZH Class II 1995-05-24
K944485 4000 AU ULTRASOUND IMAGING SYSTEM Biosound, Inc. IYO Class II 1995-05-24
K950611 EXPERT MORPHOMERTY SOFTWARD Lunar Corp. KGI Class II 1995-05-24
K950721 FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L Fujifilm Medical System U.S.A., Inc. LMC Class II 1995-05-24
K945792 IM512P Globus Industries IYX Class I 1995-05-24
K946081 FLUOREX DTA-400A Toshiba America Medical Systems, In.C JAA Class II 1995-05-24
K945796 SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM Sharplan Lasers, Inc. ITX Class II 1995-05-24
K945155 AIRIS Hitachi Medical Systems America, Inc. LNH Class II 1995-05-24
K951396 KODAK X-OMAT 3000 RA PROCESSOR Eastman Kodak Company IXW Class II 1995-05-15
K951358 SIRESKOP SX Siemens Medical Solutions USA, Inc. JAA Class II 1995-05-15
K942346 IMAGERT Impac Medical Systems, Inc. IYE Class II 1995-05-15
K944684 POLYSCAN DIGITAL SCANNER Mse Medizintechnik GmbH & Co. KG IYW Class I 1995-05-15
K951397 KODAK X-OMAT 5000 RA PROCESSOR Eastman Kodak Company IXW Class II 1995-05-15
K950423 MINI IMAGER Regulatory Management Services LMC Class II 1995-05-12
K946128 SIMULIX-HP Oldelft Corp. of America KPQ Class II 1995-05-12
K943602 DI-2000 Miles Inc., Agfa Division IYX Class I 1995-05-12
K943994 PACS EQUIPMENT Rstar Image Management System LMD Class I 1995-05-12
K951695 OPERAND* ULTRASOUND TRANSMISSION GEL Redi Products, Inc. IYN Class II 1995-05-12
K943714 MICRO MULTILEAF COLLIMATOR Leibinger F.L. Fischer IYE Class II 1995-05-12
K944196 IMWXDOP IR Imex Medical Systems, Inc. JAF Class II 1995-05-12

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