meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
36
Latest Decision
1990-01-23

Clearances · page 130 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K896486 R-150-ET COLLIMATOR Advantech IZX Class II 1990-01-23
K896475 DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD Medipart Jerry Alexander IYT Class II 1990-01-22
K896683 COMPACT VIDEO IMAGER MP4000 SERIES III International Imaging Electronics LMC Class II 1990-01-22
K896665 EXT-600 TABLE, RADIOGRAPHIC, ELEVATING Rms Div. IZZ Class II 1990-01-22
K896124 MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 Medipart Jerry Alexander IYT Class II 1990-01-22
K896476 DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD Medipart Jerry Alexander IYT Class II 1990-01-22
K896150 IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC Teknar, Inc. IYO Class II 1990-01-18
K896508 VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1990-01-12
K896029 DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20 G.W.B. Intl., Ltd. IYO Class II 1990-01-12
K895697 VAC FIX(R) SYSTEM S&S Par Scientific IYE Class II 1990-01-12
K896309 MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC Instrumentarium Imaging, Inc. LNH Class II 1990-01-12
K894568 NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM Advanced Medical Systems, Inc. KPQ Class II 1990-01-09
K896615 CINE CAMERA CONTROL MODEL PK2037 Perkins Mfg. Co. IZJ Class II 1990-01-04
K894855 MODEL 5070; DUAL PLANAR PAIR Medical Advances, Inc. LNH Class II 1990-01-04
K894722 RENNER-PLAN W.D. Renner Consulting Co. IYE Class II 1990-01-03
K896331 V2465P X-RAY IMAGE INTENSIFIER Hamamatsu Photonics K.K. JAA Class II 1989-12-22
K894412 RADIOSCOPE OR MAMMOSCOPE Vision Ten, Inc. LMA Class II 1989-12-22
K896353 GE TARGET SERIES 2 GE Medical Systems KPQ Class II 1989-12-22
K896336 MODEL SPINE SURVEYOR-PLUS; CAT. #ACS-10A Medical Advances, Inc. LNH Class II 1989-12-22
K896511 DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL E.I. Dupont DE Nemours & Co., Inc. KPY Class I 1989-12-22
K896458 ASPECT GAMMA CAMERA Digital Scintigraphics, Inc. KPS Class II 1989-12-22
K896647 GYROVIEW HR HIGH RESOLUTION WORKSTATION Philips Medical Systems North America, Inc. LNH Class II 1989-12-21
K890999 MODIFIED QDR-1000 X-RAY BONE DENSITOMETER Hologic, Inc. KGI Class II 1989-12-21
K894643 RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT Lorad Medical Systems, Inc. IZL Class II 1989-12-14
K895614 CIVCO LATEX ULTRASOUND SHEATHS CIVCO Medical Instruments Co., Inc. IYO Class II 1989-12-14
K892711 QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM Quantitative Cardiac Systems (Qcs), Inc. LLZ Class II 1989-12-14
K896289 RADIATION PROTECTION APRON Infab Corp. KPY Class I 1989-12-14
K895869 GYROSCAN T5 MOBILE Philips Medical Systems, Inc. LNH Class II 1989-12-14
K896050 FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR) Fujifilm Medical System U.S.A., Inc. LLZ Class II 1989-12-14
K894887 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF Shimadzu Medical Systems JAK Class II 1989-12-14
K895442 THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL Altek Corp. KPQ Class II 1989-12-14
K895966 MAGNETOM M, H, 42, 63, 42 SP AND 63 SP Siemens Medical Solutions USA, Inc. LNH Class II 1989-11-30
K896119 RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE Rms Div. IXR Class II 1989-11-27
K894547 RADIUS CF General Electric Co. ITX Class II 1989-11-22
K895359 ADMS MULTIPLANE RECTAL PROBE Avalon Technology Corp. ITX Class II 1989-11-22
K894016 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20 Summit World Trade Corp. LNH Class II 1989-11-22
K894381 GAMMAMED IRIDIUM-192 SOURCE Mick Radio-Nuclear Instruments, Inc. JAQ Class II 1989-11-21
K896324 ELITE 1500 RADIOGRAPHIC TILTING TABLE Rms Div. IXR Class II 1989-11-21
K892659 ELECTRODELCA Oldelft Corp. of America IZG Class II 1989-11-21
K895733 FIBERVISION(TM) Fiber Imaging, Inc. IYE Class II 1989-11-21
K894402 HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL Hipgraphics, Inc. LLZ Class II 1989-11-17
K896088 FEMORAL ANGIOGRAPHY DRAPE Medical Plastics, Inc. IZI Class II 1989-11-17
K895794 GE MR MAX SYSTEM GE Medical Systems LNH Class II 1989-11-17
K892342 TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM Bay Shore Medical Equipment Corp. IZH Class II 1989-11-17
K895034 BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C Yamato Medical Corp. IXY Class I 1989-11-15
K894056 POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W Shimadzu Medical Systems KPS Class II 1989-11-15
K895668 DIGICAM LHP (VIDEO INTERFACE OPTION) Siemens Gammasonics, Inc. LMC Class II 1989-11-15
K894714 1989 SOFTWARE REVISION TO THE BMT-1100 Bruker Medical Imaging, Inc. LNH Class II 1989-11-15
K895394 MOBILE X-RAY TELEVISION UNIT WHA-10A/B Shimadzu Corp. JAA Class II 1989-11-13
K895969 RADKOR DXG-650R Radkor, Inc. IZO Class I 1989-11-13
K895546 MODIFIED SPANTRON FRAME FREEZE Spantron, Inc. JAA Class II 1989-11-13
K894142 ULTRANET-S COLLIMATOR GE Medical Systems IZW Class II 1989-11-06
K895730 X-RAY EQUIPMENT (VARIOUS TYPES) Continental X-Ray Corp. JAA Class II 1989-11-06
K895500 PATIENT POSITIONING ACCESSORIES Perkins Mfg. Co. IYE Class II 1989-11-06
K893744 SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM Shimadzu Medical Systems LNH Class II 1989-11-06
K895100 ECHO GEL (RAINFOREST) Lead-Lok, Inc. ITX Class II 1989-11-03
K894998 MODIFIED POSICAM SYSTEM MODEL 6.5 Positron KPS Class II 1989-11-02
K895320 FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE Digivision, Inc. LLZ Class II 1989-11-01
K895151 VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1989-10-30
K893518 MT/S SOFTWARE RELEASE 5.0. Diasonics, Inc. LNH Class II 1989-10-27
K895084 APERTURE Custom Medical Products, Ltd. IZS Class II 1989-10-27
K894742 RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS Inmark Corp. ITY Class I 1989-10-27
K890799 CURIETRON 192 HIGH DOSE RATE Cis-Us, Inc. JAQ Class II 1989-10-27
K895131 MODEL 2031 TMJ SURFACE COIL Medical Advances, Inc. LNH Class II 1989-10-27
K895209 FILMFAX Discovery Systems, Inc. LMD Class I 1989-10-27
K891695 VIEW 1000 Virtual Imaging LLZ Class II 1989-10-27
K894931 SOPHYCAMERA DSX RECTANGULAR Sopha Medical Systems, Inc. IYX Class I 1989-10-27
K892397 MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS Nuccardiac Software, Inc. LLZ Class II 1989-10-27
K891689 MIPRON/UMIPRON Kontron Electronics LLZ Class II 1989-10-27
K891692 MIP MR Kontron Electronics LLZ Class II 1989-10-27
K892712 MIP/CT IMAGE PROCESSING WORKSTATION Kontron Electronics LLZ Class II 1989-10-19
K894854 QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE Image Enhancements KGI Class II 1989-10-19
K894912 SRI 100 RADIOTHERAPY IMAGING SYSTEM Philips Medical Systems, Inc. IYE Class II 1989-10-13
K895071 AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER Acoustic Imaging IYO Class II 1989-10-12
K893225 COUPLANT WARMING DEVICE Echo Ultrasound IYO Class II 1989-10-12
K894706 HT-RES RTP SYSTEM Adac Laboratories IYE Class II 1989-10-11
K894806 SIEMENS ENDO-P-PROBE Siemens Medical Solutions USA, Inc. IYO Class II 1989-10-05
K891449 SONOLINE CF Siemens Ultrasound, Inc. IYO Class II 1989-10-05
K894188 GX-ELEVATOR Gendex Corp. IZZ Class II 1989-10-03
K895221 ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42 Siemens Medical Solutions USA, Inc. LNH Class II 1989-10-03
K894834 DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEM Brymill Corp. IYO Class II 1989-10-02
K894409 CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD Amersham Corp. IWA Class II 1989-09-29
K894413 X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS Inmark Corp. ITY Class I 1989-09-22
K895188 SHIMADZU X-RAY TUBE STAND FH-31 Shimadzu Medical Systems IYB Class I 1989-09-22
K893996 CUSIS ULTRASOUND SKIN IMAGING SYSTEM Stiefel Research Institute, Inc. IYO Class II 1989-09-21
K893728 PINK CASSETTE CADDIE Medical Technique Instruments, Inc. IXA Class II 1989-09-18
K891292 SRS-200 RADIOSURGERY SYSTEM Philips Medical Systems North America, Inc. IYE Class II 1989-09-18
K893703 AFTER LOADING DEVICE KIT Medical Radiation Devices, Inc. IWJ Class I 1989-09-18
K894913 DA-100HS Fischer Imaging Corp. JAA Class II 1989-09-18
K894974 MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM Resonex, Inc. LNH Class II 1989-09-12
K894054 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER Advanced Technology Laboratories, Inc. IYN Class II 1989-09-12
K894163 PHASE 2 TRANSCRANIAL PROBE Biosound, Inc. IYN Class II 1989-09-12
K892386 DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A Toshiba America Medical Systems, In.C IYO Class II 1989-09-12
K891582 MODIFIED OSTEOANALYZER (# SPSHA110/220) Osteon, Inc. KGI Class II 1989-09-12
K894479 30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE Bennett X-Ray Corp. IZO Class I 1989-09-12
K893833 AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER Acoustic Imaging IYN Class II 1989-09-11
K894683 FABFOAM #302 Jewell Industries JAD Class II 1989-09-07
K894290 ACCESS TM Diasonics, Inc. LNH Class II 1989-09-07
K894542 ELSCINT'S EXEL 2400E CT SCANNER Elscint, Inc. JAK Class II 1989-09-07
K890913 SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT Shimadzu Precision Instruments, Inc. IYO Class II 1989-09-06

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