meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
38
Latest Decision
1990-05-09

Clearances · page 129 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K900193 MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT Imt America, Inc. OXO Class II 1990-05-09
K900967 MODIFIED ALPHA MC-9R C-ARM Instrumentarium Imaging, Inc. OXO Class II 1990-05-09
K896708 PERLINK CASSETTE, KIRAN CASSETTE Perlink USA, Inc. IXA Class II 1990-05-07
K901602 VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 Resonex, Inc. LNH Class II 1990-05-07
K900194 MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT Imt America, Inc. OXO Class II 1990-05-07
K901405 DIGIFORMER HR DFP-50A Toshiba America Medical Systems, In.C JAA Class II 1990-05-07
K896755 ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM Ge Medical Systems Information Technologies IYO Class II 1990-05-07
K901620 MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI Instrumentarium Imaging, Inc. LNH Class II 1990-05-07
K900555 INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA. Interson Corp. ITX Class II 1990-05-02
K900892 MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE Siemens Gammasonics, Inc. KPS Class II 1990-05-02
K900972 RADIATION PROTECTION GLOVES Infab Corp. IWP Class I 1990-05-01
K900970 RADIATION PROTECTION GLASSES Infab Corp. KPY Class I 1990-05-01
K900899 MP3000 COMPACT VIDEO IMAGER International Imaging Electronics LMC Class II 1990-04-30
K900900 MP3000 SERIES II COMPACT VIDEO IMAGER International Imaging Electronics LMC Class II 1990-04-30
K901423 DIGITAL IMAGE SCANNER, MODEL DIS-1000 Lumisys, Inc. LMA Class II 1990-04-30
K900896 6000 PLUS MULTI-FORMAT VIDEO IMAGER International Imaging Electronics LMC Class II 1990-04-30
K900026 BRUKER R28 WHOLE-BODY MR SCANNER Bruker Medical Imaging, Inc. LNH Class II 1990-04-30
K896739 KONICA KFDR-S Konica Medical Corp. LMA Class II 1990-04-30
K900901 MP4000 SERIES II COMPACT VIDEO IMAGER International Imaging Electronics LMC Class II 1990-04-30
K901242 MODEL 2121-64; TMJ SURFACE COIL Medical Advances, Inc. LNH Class II 1990-04-26
K901305 MODEL 2121-21, TMJ SURFACE COIL Medical Advances, Inc. LNH Class II 1990-04-26
K896555 CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT W. L. Systems, Inc. KPQ Class II 1990-04-26
K901384 MODEL 6000-21; VOLUME NECK COIL Medical Advances, Inc. LNH Class II 1990-04-26
K901241 THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64 Medical Advances, Inc. LNH Class II 1990-04-25
K901323 HYDRA VIEW IMAGING SYSTEM Mallinckrodt Group, Inc. JAA Class II 1990-04-25
K896038 B-SCAN 10 MHZ PROBE Teknar, Inc. ITX Class II 1990-04-23
K901158 LITEBOX DIAGNOSTIC REVIEW WORKSTATION Siemens Gammasonics, Inc. LLZ Class II 1990-04-19
K900897 5000/5000C MULTI-FORMAT CAMERAS FOR NUCLEAR MEDI. International Imaging Electronics LMC Class II 1990-04-19
K901153 SONY VO-5800H VIDEOCASSETTE RECORDER Sony Medical Electronics Co. JAA Class II 1990-04-19
K900689 MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA Adac Laboratories IYX Class I 1990-04-19
K900893 CARDIOVUE CFS-100 Bv Medical Equipment Co. JAA Class II 1990-04-19
K896540 ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE Nuclear Data Systems IZD Class I 1990-04-19
K900898 9000 ECONOMICAL 14 X 17 VIDEO IMAGER International Imaging Electronics LMC Class II 1990-04-19
K890531 EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE Hitachi Medical Corp. of America ITX Class II 1990-04-13
K884644 ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322 Hitachi Medical Corp. of America IYO Class II 1990-04-13
K890532 EUP-C321 5.0MHZ CONVEX TYPE PROBE Hitachi Medical Corp. of America ITX Class II 1990-04-13
K896173 ULTRASCAN(R) Topical Delivery Systems IYO Class II 1990-04-11
K901118 OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM Adac Laboratories LMB Class I 1990-04-10
K890121 MODIFIED DPX BONE DENSITOMETER Lunar KGI Class II 1990-04-10
K900562 TRANS X 100 CHEST FILM CHANGER Acoma Medical Imaging, Inc. KPR Class II 1990-04-10
K901092 MODEL 8010; EXTREMITY SURFACE COIL Medical Advances, Inc. LNH Class II 1990-04-05
K901019 DIACAM GAMMA CAMERA SYSTEM Siemens Gammasonics, Inc. KPS Class II 1990-04-04
K890486 MXR-14 FILM PROCESSOR Cordell, Inc. IXW Class II 1990-04-03
K901014 RADIOGRAPHIC INTENSIFYING SCREEN Infab Corp. EAM Class I 1990-04-02
K901013 RADIOGRAPHIC FILM CASSETTE Infab Corp. IXA Class II 1990-03-28
K900989 ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM Fischer Imaging Corp. IZH Class II 1990-03-28
K901012 RADIOGRAPHIC GRID Infab Corp. IXJ Class I 1990-03-28
K900725 RADIO FREQUENCY RECEIVER SUBSYSTEM Myheal Technologies LNH Class II 1990-03-23
K897000 IMAGEMASTER-101(TM) Columbia Scientific, Inc. LLZ Class II 1990-03-23
K892425 STP COMPLETE MODULE SET Leibinger & Fischer , Ltd. IYE Class II 1990-03-23
K900889 MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES Siemens Medical Solutions USA, Inc. LNH Class II 1990-03-23
K900885 FUJI MEDICAL LASER IMAGER Fujifilm Medical System U.S.A., Inc. LMC Class II 1990-03-23
K900283 MRT 50A SOFTWARE RELEASE 9.0 Toshiba America Mri, Inc. LNH Class II 1990-03-19
K900574 ABIOMED BODY LEAD ANALYZER MODEL 200/20 Abiomed, Inc. JAO Class II 1990-03-15
K896588 ONCOPROBE II SYSTEM Care Wise Medical Products Corp. IZD Class I 1990-03-14
K897115 ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM) Toshiba America Medical Systems, In.C IZI Class II 1990-03-13
K900660 TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE Philips Medical Systems North America, Inc. JAK Class II 1990-03-13
K900289 MRT 50A 100MM CIRCULAR SURFACE COIL Toshiba America Mri, Inc. LNH Class II 1990-03-09
K900064 VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1990-03-09
K900727 MRT 50A JOINT COIL Toshiba America Mri, Inc. LNH Class II 1990-03-09
K895328 MAGNETIC RESONANCE SYSTEM MODEL BMT-1100 Bruker Medical Imaging, Inc. LNH Class II 1990-03-09
K900288 MRT 50A BRAIN QD COIL Toshiba America Mri, Inc. LNH Class II 1990-03-09
K900284 MRT 50A 150MM CIRCULAR SURFACE COIL Toshiba America Mri, Inc. LNH Class II 1990-03-09
K900728 MRT 50A KNEE COIL Toshiba America Mri, Inc. LNH Class II 1990-03-09
K900285 MRT 50A FLEXIBLE BODY COIL Toshiba America Mri, Inc. LNH Class II 1990-03-09
K896456 TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM Toshiba America Medical Systems, In.C JAK Class II 1990-03-08
K900286 MRT 50A SPINE SURFACE COIL Toshiba America Mri, Inc. LNH Class II 1990-03-08
K900287 MRT 50A CRANIO-CERVICAL COIL Toshiba America Mri, Inc. LNH Class II 1990-03-08
K895645 BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM Biosound, Inc. IYO Class II 1990-03-06
K896583 F.A.S.T. TABLE Oec-Diasonics, Inc. IXR Class II 1990-03-01
K900620 DU PONT MAMMOGRAPHY CASSETTE E.I. Dupont DE Nemours & Co., Inc. IXA Class II 1990-02-26
K900234 PFM-90 CEILING TUBE SUPPORT Fischer Imaging Corp. IYB Class I 1990-02-26
K900367 HOFMANN-NAGEL (HOFNA) X-RAY TUBES Hofmann ITY Class I 1990-02-26
K896885 DISPOSABLE RESPIRTORY KIT (MP-200) Medipart Jerry Alexander IYT Class II 1990-02-26
K900233 TCT-300S - UPGRADE Toshiba America Medical Systems, In.C JAK Class II 1990-02-26
K900586 MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE Medrad, Inc. LLZ Class II 1990-02-23
K896387 SXT-60F/60M MOBILE C ARM X-RAY UNIT Toshiba America Medical Systems, In.C OXO Class II 1990-02-23
K895147 QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM Quantum Intl. IYO Class II 1990-02-23
K897098 SIEMENS ENDO-P-PROBE Siemens Medical Solutions USA, Inc. ITX Class II 1990-02-23
K895335 CRONEX COMPACT MAMMOGRAPHY CASSETTE E.I. Dupont DE Nemours & Co., Inc. IXA Class II 1990-02-16
K896949 MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS Innovative Products Mfg. EAK Class I 1990-02-16
K900448 CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1990-02-16
K896095 IMAGES-ON-CALL TELERADIOLOGY SYSTEM Devices & Services Co. LMD Class I 1990-02-16
K900227 MVP (MULTI-VENDOR PROTOCOL CONVERTOR) Merge Technologies, Inc. LMD Class I 1990-02-12
K896223 PHOTOPHONE Image Data Corp. LMA Class II 1990-02-12
K900007 R-100-ET MANUAL COLLIMATOR Advantech IZX Class II 1990-02-06
K900062 U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL U.S. Imaging, Inc. IZO Class I 1990-02-05
K900103 CRONEX QUANTA SR300 INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1990-02-05
K900318 CRONEX QUANTA SUPER RAPID SR339 RARE EARTH E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1990-02-05
K893861 TMI LW-100 PULSED DOPPLER SYSTEM Titronics Medical Instruments, Inc. IYN Class II 1990-02-05
K896419 MODEL: GYREX VERSION V Elscint, Inc. LNH Class II 1990-02-02
K895629 MODEL 8100; UPPER EXTREMITY COIL Medical Advances, Inc. LNH Class II 1990-02-02
K894165 THERATRON 1000 Theratronics, Inc. IWB Class II 1990-02-01
K895799 RECTILINEAR SCANNER MODEL #187-270 Atomic Products Corp. IYW Class I 1990-02-01
K896125 MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M Medipart Jerry Alexander IYT Class II 1990-02-01
K890294 INTER-PAL C-19 AND INTER-PAL C-38 Enrad Corp. JAQ Class II 1990-02-01
K896609 CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC Philips Medical Systems North America, Inc. IZH Class II 1990-01-31
K894888 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE Shimadzu Medical Systems JAK Class II 1990-01-23
K896677 PC/QCT QUANTITATIVE SOFTWARE The Institute For Radiological Image Sciences, Inc. KGI Class II 1990-01-23
K896789 MODEL 6000; VOLUME NECK COIL Medical Advances, Inc. LNH Class II 1990-01-23

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