meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
31
Latest Decision
1996-03-29

Clearances · page 109 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K954691 ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM Access Radiology Corp. LMD Class I 1996-03-29
K955484 XENON OPTION TO PRISM 3000 Philips Medical Systems (Cleveland), Inc. KPS Class II 1996-03-29
K955811 AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 1996-03-29
K960043 KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM Jamieson Film Co. LLZ Class II 1996-03-27
K951998 DIASONICS MASTERS SERIES 5000 ULTRASOUND SCANNER Diasonics Ultrasound IYN Class II 1996-03-27
K935123 SUPERSTAND 300 Wuestec Medical, Inc. IYB Class I 1996-03-27
K960241 CPR GENERAL SURGERY TRAY Custom Pack Reliability LWI Class II 1996-03-22
K960602 SSA-340A (MODIFICATION) Toshiba America Medical Systems, In.C IYN Class II 1996-03-21
K955411 DELTA 16 Instrumentarium Imaging, Inc. IZH Class II 1996-03-21
K960082 DISCOGRAPHY KIT Spinal Specialties, Inc. IZG Class II 1996-03-21
K954159 DIGITAL IMAGING SYSTEM Camtronics, Ltd. LLZ Class II 1996-03-19
K954172 X-RAY VISIONS Image Visions, LLC LMD Class I 1996-03-15
K946277 TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM Tetra Corp. IYN Class II 1996-03-15
K954467 CADPLAN BT Varian Assoc., Inc. JAQ Class II 1996-03-15
K955942 BLADDERSCAN BVI 5000 Diagnostic Ultrasound Corp. IYO Class II 1996-03-15
K951261 DFI-1000 AND DVS-475 IMAGING DEVICES Nical JAA Class II 1996-03-15
K953752 RT55 DIAGNOSTIC ULTRASOUND SYSTEM General Electric Co. IYO Class II 1996-03-15
K955774 VARIS PORTALVISION Varian Assoc., Inc. IYE Class II 1996-03-15
K953773 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE Medison America, Inc. IYO Class II 1996-03-14
K953673 ECLIPSE PROBE COVER Parker Laboratories, Inc. IYO Class II 1996-03-14
K954952 MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL Medrad, Inc. MOS Class II 1996-03-13
K960198 DIGISCOPE RX-2 Medirex, Inc. OXO Class II 1996-03-12
K952540 SONOS IMAGING SYSTEM (2000/2500 & 1000/1500) Hewlett-Packard Co. IYO Class II 1996-03-11
K960266 SIREGRAPH CF Siemens Medical Solutions USA, Inc. JAA Class II 1996-03-11
K950943 ULTRA EASE Lectec Corp. IYO Class II 1996-03-07
K953391 TREATMENT MANAGEMENT SYSTEM Siemens Medical Solutions USA, Inc. LHN Class II 1996-03-07
K960326 FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM Fujifilm Medical System U.S.A., Inc. LMB Class I 1996-03-07
K960181 VERSION 3.7 OPERATING SYSTEM SOFTWARE Hitachi Medical Systems America, Inc. LNH Class II 1996-03-05
K955708 COMPUMED DICON CLIENT Compumed, Inc. LMD Class I 1996-03-01
K953819 DIAGNOSTIC ULTRASOUND TRANDUCER Biosound, Inc. ITX Class II 1996-03-01
K953759 DIAGNOSTIC ULTRASOUND TRANSDUCER Biosound, Inc. ITX Class II 1996-03-01
K955643 ALARA IMAGING SYSTEM Denoptix, Inc. EGY Class II 1996-03-01
K955626 MEDRAD/HITACHI BREAST IMAGING SURFACE COIL Medrad, Inc. MOS Class II 1996-02-27
K960146 G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY GE Medical Systems IZG Class II 1996-02-27
K953616 PREVIEW SURGERY PLANNING SOFTWARE Medical Media Systems LLZ Class II 1996-02-27
K954071 IDXVIEW Idx Systems Corp. LMD Class I 1996-02-27
K953508 COMPUTE-RX PLAN PC3D Medicalibration Physics Consultant Services, Inc. IYE Class II 1996-02-26
K954874 SPECTEF PROTOCOL GE Medical Systems KPS Class II 1996-02-26
K950837 AURORA IMAGING SYSTEM Advanced Mammography Systems, Inc. LNH Class II 1996-02-26
K955394 SIENET TELERADIOLOGY PRODUCT LINE Siemens Medical Solutions USA, Inc. LMC Class II 1996-02-21
K954479 DICOMVIEW Heartlab, Inc. LMD Class I 1996-02-21
K952238 VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE) Imaging Concepts, Inc. LMB Class I 1996-02-21
K955246 ECOGEL 200 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc. ITX Class II 1996-02-21
K953634 SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems IYO Class II 1996-02-13
K955706 JPI AUTOMATIC X-RAY FILM PROCESSOR Jpi Healthcare Co, Ltd. IXW Class II 1996-02-12
K955458 ULTRASOUND PROBE BIOPSY ACCESSORIES Biosound, Inc. ITX Class II 1996-02-12
K952892 OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) Olympus America, Inc. ITX Class II 1996-02-12
K943315 ULTRASOUND SCANNER 2002 B&K Medical IYO Class II 1996-02-09
K955255 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX Shimadzu Medical Systems JAK Class II 1996-02-09
K943224 VARIAN MULTILEAF COLLIMATOR Varian Assoc., Inc. IYE Class II 1996-02-02
K954294 HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES Thermotrex Corp. IXJ Class I 1996-02-02
K953579 TEE PROBE Biosound, Inc. ITX Class II 1996-02-02
K954161 JPI INTENSIFYING SCREEN Jpi Healthcare Co, Ltd. EAM Class I 1996-02-02
K955268 PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM Philips Medical Systems (Cleveland), Inc. JAK Class II 1996-01-30
K954945 HANEL MAVIG MONITOR SUSPENSION SYSTEM F. Walter Hanel GmbH JAA Class II 1996-01-29
K954998 LILY DARK VIEWER Lily Imaging Solutions Co. IXC Class I 1996-01-29
K955000 REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE Cerner Corp. LMD Class I 1996-01-26
K953250 SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE GE Medical Systems IZH Class II 1996-01-26
K955253 SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH Shimadzu Medical Systems JAK Class II 1996-01-26
K955254 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC Shimadzu Medical Systems JAK Class II 1996-01-26
K955184 ACCULUPE E For M Imaging Systems Div., Marquette Electronic LMB Class I 1996-01-24
K952190 TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE Sopha Medical Systems, Inc. KPS Class II 1996-01-18
K953117 SCANMASTER DX Howtek, Inc. LMA Class II 1996-01-18
K954646 EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS Philips Medical Systems (Cleveland), Inc. LNH Class II 1996-01-18
K952314 EXL-12SP & 12DP LINAC Mitsubishi Intl. Corp. IYE Class II 1996-01-17
K954022 ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 1996-01-17
K954705 ACRYSTEEL BLOCKING TRAY Medtec, Inc. IYE Class II 1996-01-05
K951999 HOLOPSY SYSTEM Neovision Corp. IYO Class II 1996-01-05
K954248 SIEMENS VIRTURAL WEDGE Siemens Medical Solutions USA, Inc. IXI Class II 1996-01-05
K954589 CLARK TUT IMAGE PROCESSING SYSTEM Clark Research and Development, Inc. LLZ Class II 1996-01-05
K954678 PRO VISION Algotec Systems, Ltd. LLZ Class II 1996-01-05
K955185 GE ADVANTAGE DICOM CR REPROCESSING STATION GE Medical Systems LLZ Class II 1996-01-03
K954875 ASPECT ACQUISITION MODULE (AAM) Aspect Electronics, Inc. LMA Class II 1996-01-02
K955036 MOBILE X-RAY SYSTEM Shimadzu Corp. IZL Class II 1995-12-22
K954129 SPECTRADIGITAL SERIES V250DSP Hitachi Medical Corp. of America KPS Class II 1995-12-22
K953942 COBRASCAN CX-312 Radiographic Digital Imaging, Inc. LMA Class II 1995-12-22
K954143 HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS Hitachi Medical Corp. of America KPS Class II 1995-12-22
K945945 GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT Philips Medical Systems North America, Inc. LNH Class II 1995-12-22
K941352 SSA-340A Toshiba America Medical Systems, In.C IYN Class II 1995-12-22
K954634 RADIOSURGERY VERIFICATION PHANTOM The Phantom Laboratory, Inc. IYE Class II 1995-12-22
K955249 SENSOR PAD Inventive Products, Inc. IZH Class II 1995-12-22
K955095 SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM Sierra Battery, Inc. IZL Class II 1995-12-21
K954581 ARC SERIES Continental X-Ray Corp. IZI Class II 1995-12-21
K954860 ECHONET Heartlab, Inc. LLZ Class II 1995-12-21
K954456 THERMOPLASTIC SHIELD Medtec, Inc. KPY Class I 1995-12-21
K952108 EXL-15DP & 20-DP LINAC Mitsubishi Intl. Corp. IYE Class II 1995-12-21
K946074 ALDERSON BREST DOSIMETRY SYSTEM Radiology Support Devices, Inc. IYE Class II 1995-12-21
K944612 ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM Codman & Shurtleff, Inc. LLZ Class II 1995-12-11
K955395 DAR-2400-15B/30B Shimadzu Medical Systems IZI Class II 1995-12-11
K955232 NT SERIES DIGITAL IMAGE MANAGER Camtronics, Ltd. LMB Class I 1995-12-11
K952551 JANUS I 3D Ultrasound, Inc. IYO Class II 1995-12-11
K954222 VIDEO ENHANCEMENT UNIT Perkins Mfg. Co. LLZ Class II 1995-12-08
K954146 UTK-DTE AUTILARY SHIELD Mallinckrodt Medical KPY Class I 1995-12-06
K954211 CRISPICS Merlin Engineering Works, Inc. LLZ Class II 1995-12-05
K954165 PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM Ptw-New York Corp. IYE Class II 1995-12-05
K953404 OSTEO-RAY 100 Micro Focus Imaging, Inc. IZL Class II 1995-11-30
K954039 GYREX PRIVILEGE Elscint, Inc. LNH Class II 1995-11-24
K954666 MPH50, MPH65, AND MPH80 GE Medical Systems IZO Class I 1995-11-24
K953259 VOXELVIEW Vital Images, Inc. LLZ Class II 1995-11-24
K952485 LASERNET IMAGE MANAGER/PRINT SERVER Frantz Imaging, Inc. LMA Class II 1995-11-24

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