meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
36
Latest Decision
1989-04-19

Clearances · page 132 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K885054 SYSTEM SEVENTY SEVEN Scinticor, Inc. IYX Class I 1989-04-19
K884672 APEX 115 NUCLEAR MEDICINE PROCESSOR Elscint, Inc. IYX Class I 1989-04-17
K884674 APEX 415 ANGER CAMERA Elscint, Inc. IYX Class I 1989-04-17
K890306 BCM-ARC 105 X-RAY MOBILE UNIT B C Medical , Ltd. IZL Class II 1989-04-17
K884675 APEX 609R ANGER CAMERA Elscint, Inc. IYX Class I 1989-04-17
K891266 NEUROFOCAL COLLIMATOR Siemens Gammasonics, Inc. KPS Class II 1989-04-17
K890485 WANG FRONT LOADING APPLICATOR Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1989-04-14
K891377 HILARIS-NORI CERVIX APPLICATOR Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1989-04-14
K890666 MODEL 3031; CERVICAL SPINE SURFACE COIL Medical Advances, Inc. LNH Class II 1989-04-14
K882449 CESIUM 137 SOURCE, MODEL CSM-40 Cis-Us, Inc. IWI Class II 1989-04-14
K890397 REDI-VU MODEL RV-386 J.D. Technical Services LLZ Class II 1989-04-14
K890173 INTERSPEC APOGEE Interspec, Inc. IYO Class II 1989-04-14
K884673 APEX 215M MOBILE ANGER CAMERA Elscint, Inc. IYX Class I 1989-04-14
K890100 PENN-PET SCANNER Ugm Medical Systems, Inc. KPS Class II 1989-04-13
K884661 D-SCOPE III Medx, Inc. IYX Class I 1989-04-12
K891090 SPECBOARD Macbrud Corp. Medical Div. IZH Class II 1989-04-07
K891192 MEDI-TRACE THERMAL VIDEO FILM PAPER Graphic Controls Corp. LMD Class I 1989-04-06
K873038 TECHTON PROTECTIVE PAD Techton, Inc. IWQ Class I 1989-04-03
K884323 XIMAVIEW(TM) Varian Assoc., Inc. KPQ Class II 1989-04-03
K890815 MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES Siemens Medical Solutions USA, Inc. LNH Class II 1989-04-03
K891395 RADKOR BS-10 AND BS-10T Radkor, Inc. IXY Class I 1989-04-03
K884292 STRETCHER TABLE Fischer Imaging Corp. KXH Class I 1989-03-31
K890083 GX-2000 STATIONARY X-RAY GENERATOR Gendex Corp. IZO Class I 1989-03-31
K883917 NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT Sonomed Technology, Inc. IYO Class II 1989-03-31
K890477 THE SPANTRON FRAME FREEZE Spantron, Inc. LMA Class II 1989-03-31
K885242 MICRODELTA II Siemens Gammasonics, Inc. IYX Class I 1989-03-30
K890066 STAR 36 Transworld X-Ray Corp. IZO Class I 1989-03-28
K884345 MODEL ESP-200 MAMMOGRAPHIC SYSTEM Acoma Medical Imaging, Inc. IZH Class II 1989-03-23
K884990 IMS-3 PICTURE ARCHIVING SYSTEM The Biomedical Engineering Center LMB Class I 1989-03-23
K885081 SIMRITE VERIFICATION AND SIMULATION SYSTEM Haynes Radiation Ltd., Inc. KPQ Class II 1989-03-22
K884650 RESUBMITTED SCANORA Orion Corp. IZF Class II 1989-03-16
K884477 SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B Shimadzu Precision Instruments, Inc. KPR Class II 1989-03-15
K884028 MULTI CAMERA CONTROL UNIT (MCCU) Leybold-Inficon, Inc. JAA Class II 1989-03-15
K881865 NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER Norland Corp. KGI Class II 1989-03-14
K890483 THE PATHFINDER SYSTEM Denmark Assoc. IZH Class II 1989-03-14
K885155 MENTOR MDS Imex IYN Class II 1989-03-14
K890745 SC-1000 WITH SUFFIXES (SCAN CONVERTER) Eigen JAA Class II 1989-03-14
K890394 MEDRAD SCPD 1000 Medrad, Inc. LNH Class II 1989-03-14
K885207 KODAK MULTILOADER 700 Eastman Kodak Company IXW Class II 1989-03-14
K885047 VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1989-03-14
K881336 BRYMASCAN-A Brymill Corp. IYO Class II 1989-03-14
K890341 MICK 200-TP AND MICK TP NEEDLE Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1989-03-14
K885228 RT6800 ECHOCARDIOGRAPHY SYSTEM General Electric Co. IYO Class II 1989-03-14
K890878 PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD U.S. Imaging, Inc. JAA Class II 1989-03-14
K885135 MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150 Bennett X-Ray Corp. IZH Class II 1989-03-09
K884917 RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM Amg Medical Equipments, Inc. IZH Class II 1989-03-09
K882585 CAVROLAB Life-Tech Intl., Inc. IYN Class II 1989-03-02
K890750 KODAK X-OMATIC RA CASSETTE Eastman Kodak Company IXA Class II 1989-03-01
K884995 SIEMENS PACS/1-B (OPTICAL DISK OPTION) Siemens Gammasonics, Inc. LLZ Class II 1989-02-28
K883324 DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) Siemens Gammasonics, Inc. LMC Class II 1989-02-27
K884555 TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM Toshiba Medical Systems JAK Class II 1989-02-27
K890348 LC, CARDIAC POSITIONER #B5078A General Electric Co. IZI Class II 1989-02-27
K884788 TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM Toshiba Medical Systems JAK Class II 1989-02-27
K890361 KODAK MIN-R 2 CASSETTE Eastman Kodak Company IXA Class II 1989-02-24
K874778 KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR Eastman Kodak Company LMA Class II 1989-02-23
K890352 MULTISKOP Siemens Medical Solutions USA, Inc. IZI Class II 1989-02-22
K885318 DIGITRON 3, LV ANALYSIS PROTCOL Siemens Gammasonics, Inc. LLZ Class II 1989-02-17
K885223 RMI SHORT DISTANCE ALIGNMENT DEVICE Radiation Measurements, Inc. LNH Class II 1989-02-17
K884912 ANGIOSTAR Siemens Medical Solutions USA, Inc. IZI Class II 1989-02-16
K890467 KODAK PORTABLE IDENTIFICATION CAMERA Eastman Kodak Company JAC Class I 1989-02-16
K885127 SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM Fischer Imaging Corp. LMC Class II 1989-02-16
K890097 KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000 Eastman Kodak Company LMC Class II 1989-02-16
K884312 ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 Atomic Products Corp. KPT Class II 1989-02-16
K884578 POLARIX 2 AND POLARIX 2E Dyna-Med JAA Class II 1989-02-09
K885322 3D/DENTAL Columbia Scientific, Inc. JAK Class II 1989-02-09
K882933 DACA-100 Visual Cybernetics LLZ Class II 1989-02-08
K890191 HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN Amersham Corp. IWJ Class I 1989-02-06
K885178 KODAFLEX II RADIATION THERAPY L CASSETTE Eastman Kodak Company IXA Class II 1989-02-03
K884816 ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY Diasonics, Inc. LNH Class II 1989-02-02
K884827 KODAK DENTAL BARRIER PAC Eastman Kodak Company IWZ Class I 1989-01-30
K883359 DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A Toshiba Medical Systems IYO Class II 1989-01-25
K883898 MAGNETOM 42 SP AND MAGNETOM 63 SP Siemens Medical Solutions USA, Inc. LNH Class II 1989-01-24
K884434 VORTECH'S MEDICAL IMAGING GATEWAY Vortech Data, Inc. LMD Class I 1989-01-19
K884670 EXEL 1800 AND 1800E CT SCANNER Elscint, Inc. JAK Class II 1989-01-18
K884671 EXEL 2400 AND 2400 ELITE CT SCANNERS Elscint, Inc. JAK Class II 1989-01-18
K881323 CURIETRON 192 LOW DOSE RATE Compagnie Oris Industrie, S.A. JAQ Class II 1989-01-17
K884484 MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL Siemens Medical Solutions USA, Inc. LNH Class II 1989-01-17
K884678 ESP 3-PHASE X-RAY GENERATORS Elscint, Inc. IZO Class I 1989-01-17
K884632 ACUSON I5100 ULTRASOUND TRANSDUCER Acuson Corp. IYO Class II 1989-01-13
K884493 HEAD HOLDING DEVICE/SLEEP APNEA X-Ray Systems IWY Class I 1989-01-12
K884531 BETA 90/50 MOBILE IMAGING TABLE Beta Medical Products Co. IXR Class II 1989-01-11
K884395 HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS Hewlett-Packard Co. IYO Class II 1989-01-10
K884299 APA-C CATALOG NUMBER A-8001-C Ausonics Pty , Ltd. IYO Class II 1989-01-10
K883580 UNIVERSAL ABC CONTROLER Philips Medical Systems (Cleveland), Inc. JAA Class II 1989-01-09
K884847 MTD HEDREST Composites Horizons, Inc. IWY Class I 1989-01-09
K884676 MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. Elscint, Inc. IZH Class II 1989-01-06
K884677 MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. Elscint, Inc. IZH Class II 1989-01-06
K884770 ONCOPROBE SYSTEM Care Wise Medical Products Corp. IZD Class I 1989-01-04
K884595 OPHTHASCAN MINI-B Biophysic Medical, Inc. IYO Class II 1989-01-03
K884668 EXEL 1002 CT SCANNER Elscint, Inc. JAK Class II 1988-12-30
K884667 EXEL 905 SERIES CT SCANNER Elscint, Inc. JAK Class II 1988-12-30
K884669 EXEL 2002 & 2002FS CT SCANNER Elscint, Inc. JAK Class II 1988-12-30
K884349 ADAC VIEWPOINT (ADDITIONAL SOFTWARE) Adac Laboratories KPS Class II 1988-12-22
K884930 COMPAX MODEL 40, 400, 400T General Electric Co. IZZ Class II 1988-12-22
K882484 CMS RECORD AND VERIFY SYSTEM Computerized Medical Systems, Inc. JAD Class II 1988-12-21
K884607 MT/S (SOFTWARE RELEASE 3.1) Diasonics, Inc. LNH Class II 1988-12-21
K884317 MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM Medrad, Inc. JAA Class II 1988-12-20
K884268 VOXELSCOPE(TM) Dynamic Digital Displays, Inc. JAK Class II 1988-12-20
K883925 UROIMAGER Ausonics Pty , Ltd. IYO Class II 1988-12-15
K883079 WWDS-005 HUMAN RECTAL PROBE Ausonics Pty , Ltd. IYO Class II 1988-12-14

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