meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
28
Latest Decision
1997-03-28

Clearances · page 106 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K961782 BIO-BINKI Biomni Medical Systems, Inc. JAA Class II 1997-03-28
K970402 DOCTORS REVIEW SYSTEM Digisonics, Inc. LLZ Class II 1997-03-26
K961459 LEVEL 10 HDI Advanced Technology Laboratories, Inc. IYO Class II 1997-03-26
K962010 EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS Philips Medical Systems (Cleveland), Inc. LLZ Class II 1997-03-21
K970293 FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 Fujifilm Medical System U.S.A., Inc. LMD Class I 1997-03-21
K970640 PHILIPS EASY DIAGNOST Philips Medical Systems North America, Inc. IXR Class II 1997-03-21
K964167 DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) Multidata Systems International Corp. IYE Class II 1997-03-21
K963706 PHILIPS SONO DIAGNOST 800 Hewlett-Packard Co. IYO Class II 1997-03-19
K953902 GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM Medical Marketing Intl., Inc. IZH Class II 1997-03-19
K970034 SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. ITX Class II 1997-03-17
K970064 AMICAS WEB/INTRANET IMAGE SERVER Autocyt Group, Inc. LMD Class I 1997-03-17
K963315 VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE Vingmed Sound, Inc. IYO Class II 1997-03-17
K965161 SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) Sectra-Imtec AB LMD Class I 1997-03-12
K970037 TARGOGRID Daum GmbH LNH Class II 1997-03-12
K955179 CONTRAST MEDIA SET B.Braun Medical, Inc. IZI Class II 1997-03-12
K970240 DIFFUSER PANEL Focused Viewer, Inc. IXC Class I 1997-03-11
K970063 SERIES 7600 MOBILE DIGITAL C-ARM Ge Dec Medical Systems OWB Class II 1997-03-11
K963273 VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION Smv America KPS Class II 1997-03-11
K965004 C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER Siemens Medical Solutions USA, Inc. JAK Class II 1997-03-11
K964865 PVK-720ST ENDOCAVITARY TRANSDUCER Toshiba America Medical Systems, In.C ITX Class II 1997-03-10
K964910 AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS Alpha-Omega Services, Inc. JAQ Class II 1997-03-10
K964890 ANATOM 2000 Analogic Corp. JAK Class II 1997-03-06
K970047 PHASED ARRAY TRANSDUCER - - PSK-20CT Toshiba America Medical Systems, In.C ITX Class II 1997-03-04
K964806 MD-1835 Fischer Imaging Corp. IXL Class II 1997-03-04
K964834 ISOCAM II (DUAL HEAD GAMMA CAMERA) Park Medical Systems, Inc. KPS Class II 1997-02-28
K964820 MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A Us Asia Instruments, Inc. MOS Class II 1997-02-28
K964813 MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: Medical Advances, Inc. MOS Class II 1997-02-26
K964990 HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) Hitachi Medical Systems America, Inc. JAA Class II 1997-02-26
K963406 UHE COLLIMATOR (210591) Philips Medical Systems (Cleveland), Inc. KPS Class II 1997-02-26
K964322 VIPOR UNIT Tilane Corp. JAA Class II 1997-02-26
K964778 HI-STAR MRI IMAGING SYSTEM Health Images, Inc. LNH Class II 1997-02-24
K964752 KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER Philips Medical Systems (Cleveland), Inc. LNH Class II 1997-02-24
K964699 RHEO DOPPLEX II (RD 2) Huntleigh Technology, Inc. IYN Class II 1997-02-21
K964712 PRISM XPVT SYSTEM (210823) Philips Medical Systems (Cleveland), Inc. KPS Class II 1997-02-21
K961073 ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) Atlantis Diagnostics Intl., Inc. IYO Class II 1997-02-19
K940942 COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER Medison America, Inc. IYO Class II 1997-02-19
K964668 MODELS EXL AND EXS EXTREMITY COIL SET Mri Devices Corp. MOS Class II 1997-02-18
K964658 OASIS Sonotech, Inc. ITX Class II 1997-02-14
K964740 THE NOMOS MINICRANE Nomos Corp. JAI Class II 1997-02-11
K964678 PHASED ARRAY NECK COIL Philips Medical Systems (Cleveland), Inc. MOS Class II 1997-02-11
K964753 MATRIX 3000 FLEXIBLE SPINE COIL Us Asia Instruments, Inc. LNH Class II 1997-02-11
K964803 UNIVISION ECHOCARDIOLOGY SYSTEM Network Concepts, Inc. LMB Class I 1997-02-11
K955543 ULTRASOUND SYSTEM MODEL UF-3500 Fukuda Denshi USA, Inc. IYO Class II 1997-02-11
K964840 BEAM BLOCK TRAYS Aktina Medical Physics Corp. IYE Class II 1997-02-11
K964854 MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL Medrad, Inc. MOS Class II 1997-02-11
K964747 SOMATOM PLUS 4 CT SCANNER Siemens Medical Solutions USA, Inc. JAK Class II 1997-02-10
K964647 NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE North American Scientific, Inc. KXK Class II 1997-02-10
K963730 PROTEC (1024) Proportional Technologies, Inc. KPS Class II 1997-02-10
K961321 GAMMA GUIDANCE SYSTEM Radiation Monitoring Devices, Inc. IZD Class I 1997-02-10
K964626 EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE Philips Medical Systems (Cleveland), Inc. LNH Class II 1997-02-10
K963831 SHEATHES (NON-LATEX) Medical Resources ITX Class II 1997-02-10
K961974 FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE Pentax Precision Instrument Corp. ITX Class II 1997-02-10
K962335 MLC FIT Impac Medical Systems, Inc. IYE Class II 1997-02-06
K963302 TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM Tayman Medical, Inc. ITX Class II 1997-02-06
K962105 PLANNED SOPHIED CLASSIC Planmed OY IZH Class II 1997-02-05
K964485 PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM Eliav , Ltd. IYE Class II 1997-02-04
K964608 MRT-35A V9.0 Toshiba America Mri, Inc. LNH Class II 1997-02-04
K964141 GE STERILE DISPOSABLE EQUIPMENT COIL COVER Contour Fabricators, Inc. MOS Class II 1997-01-30
K965105 ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 U.S. Imaging Tables, Inc. IXR Class II 1997-01-30
K964414 LR 5200 LASER FILM RECORDER Bayer Corp., Agfa Div. LMC Class II 1997-01-27
K965096 FLUOROVIEW SERIES FLUOROSCOPIC TABLES U.S. Imaging Tables, Inc. IXR Class II 1997-01-27
K970059 KODAK MINILOADER(2000) Eastman Kodak Company IXW Class II 1997-01-27
K964746 HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION GE Medical Systems JAK Class II 1997-01-24
K964531 PROFILE 70000 QUADRATURE VOLUME NECK COIL Us Asia Instruments, Inc. LNH Class II 1997-01-24
K963851 TILTING RADIOGRAPHIC TABLE (REMOTE) Acoma Medical Imaging, Inc. IXR Class II 1997-01-23
K961002 DIASONICS ITNRAOPERATIVE PROBES Diasonics Ultrasound ITX Class II 1997-01-22
K962796 NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM Medasonics, Inc. IYN Class II 1997-01-21
K962153 DIGITAL IMAGE ANALYSIS SYSTEM University of Washington LLZ Class II 1997-01-17
K965013 DIGISCOPE RX-2 (9 OPTION) Medirex, Inc. OXO Class II 1997-01-17
K964306 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY General Electric Co. LNH Class II 1997-01-17
K964583 XRT-7.0 Elscint, Inc. JAK Class II 1997-01-17
K964327 IPU RX-2 Medirex, Inc. LLZ Class II 1997-01-17
K962249 PIXELL MRI SYSTEM General Medical Equipment Corp. LNH Class II 1997-01-10
K964370 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems LNH Class II 1997-01-10
K962100 VOLMETRIC COINCIDENCE DETECTION SYSTEM Elscint, Inc. KPS Class II 1997-01-10
K964576 PROFILE MAMMOGRAPHY SYSTEM (M-PRO) Bennett X-Ray Corp. IZH Class II 1997-01-10
K964318 PHILIPS TOMOSCAN AV EXPANDER UPGRADE Philips Medical Systems North America, Inc. JAK Class II 1997-01-10
K964274 WRITESTAR, AND VIEWSTAR Comview Corp. LMB Class I 1997-01-10
K964138 VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE Varian Medical Systems, Inc. KPQ Class II 1997-01-10
K964012 GENIE PROCESSING AND REVIEW WORKSTATION GE Medical Systems KPS Class II 1997-01-07
K961400 RFA-300, LDA UTILITY Scanditronix Medical AB IYE Class II 1997-01-03
K962662 VINGMED SOUND COLOR FLOW MAPPING SYSTEM Diasonics, Inc. IYO Class II 1997-01-02
K963952 SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM Ge Dec Medical Systems OWB Class II 1996-12-23
K962093 ULTRAMIX Sonotech, Inc. ITX Class II 1996-12-23
K962138 FLEXART V3.1 SOFTWARE Toshiba America Mri, Inc. LNH Class II 1996-12-23
K963980 PHILIPS EASYVISION Philips Medical Systems North America, Inc. LLZ Class II 1996-12-23
K960948 SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A Toshiba Medical Systems KPS Class II 1996-12-23
K963860 THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM Nomos Corp. IYE Class II 1996-12-23
K961601 H.A.M. APPLICATOR Mick Radio-Nuclear Instruments, Inc. JAQ Class II 1996-12-23
K962840 ECOLOTION TRANSMISSION AND MASSAGE LOTION Eco-Med Pharmaceuticals, Inc. ITX Class II 1996-12-23
K963861 LASERSHARE PRINT SPOOLER AND/OR SOFTWARE Dejarnette Research Systems LMD Class I 1996-12-18
K963859 QLVA PLUS Sanders Data Systems, LLC LLZ Class II 1996-12-18
K963953 IMIG-MRI Imig-Mri Systems, LLC LNH Class II 1996-12-18
K963888 C-ARM TABLE IVS-100 Shimadzu Medical Systems JAA Class II 1996-12-18
K960839 FILM SCANNER 300 Cannon U.S.A., Inc. LMA Class II 1996-12-18
K963896 MOBILE CT PROSPEED FAMILY GE Medical Systems JAK Class II 1996-12-18
K964124 PHILIPS COMPUTED RADIOGRAPHY Philips Medical Systems, Inc. LLZ Class II 1996-12-18
K963807 TOMTEC ECHO-SCAN Tomtec Imaging Systems, Inc. IYO Class II 1996-12-18
K964250 LINX NETWORKING SYSTEM Sterling Diagnostic Imaging, Inc. LMD Class I 1996-12-18
K963743 MANAN PROSTATE UNI-LOCK Manan Medical Products, Inc. IWJ Class I 1996-12-06

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