meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
34
Latest Decision
1994-04-15

Clearances · page 116 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K926187 POSICAST IMMOBILIZATION SYSTEM Huestis Machine Corp. IYE Class II 1994-04-15
K935021 HANDI-FOAM Medtec, Inc. IYE Class II 1994-04-07
K933460 DVFX, MODEL M256 Xre Corp. IZI Class II 1994-04-07
K934373 MOBILE SOPHIE MODIFICATION Planmed OY IZH Class II 1994-04-07
K911783 ALLEGRO VIEWING WAND I.S.G. Technologies, Inc. LLZ Class II 1994-04-07
K924985 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION Siemens Medical Solutions USA, Inc. JAK Class II 1994-04-07
K933115 DIGITAL DISK RECORDER Eigen LMB Class I 1994-04-07
K935498 7500 DATA TOWER E-Systems, Inc. LMB Class I 1994-04-01
K935670 VERSION 3 OPERATING SYSTEM SOFTWARE Hitachi Medical Systems America, Inc. LNH Class II 1994-03-30
K941023 RAREX GREEN FAST Mci Optonix, Inc. EAM Class I 1994-03-30
K935671 2D, 3D TOF MR ANGIOGRAPHY Hitachi Medical Systems America, Inc. LNH Class II 1994-03-30
K935752 CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS Siemens Medical Solutions USA, Inc. LNH Class II 1994-03-29
K932701 CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS Nuccardiac Software, Inc. IYX Class I 1994-03-29
K935627 CP BODY ARRAY/ CP SPINE ARRAY COIL Siemens Medical Solutions USA, Inc. LNH Class II 1994-03-29
K940300 MAGELLAN GE Medical Systems KPS Class II 1994-03-29
K935450 PHASED ARRAY PELVIC COIL Medical Advances, Inc. LNH Class II 1994-03-25
K940478 ECAT PRT Cti Pet Systems, Inc. KPS Class II 1994-03-22
K932848 SIMULIX-MC CT EXTENSION Oldelft Corp. of America JAK Class II 1994-03-22
K940558 3M XP-2000 X-RAY FILM PROCESSOR 3M Company IXW Class II 1994-03-22
K934350 KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS Eastman Kodak Company IXW Class II 1994-03-21
K935369 FAST SPIN ECHO (FSE) Resonex, Inc. LNH Class II 1994-03-21
K933296 MODEL #310GE1500 WRIST COIL Medic, Inc. LNH Class II 1994-03-17
K936086 STERILE VIDEO CAMERA COVER AND DRAPE Micromedical Devices, Inc. KXK Class II 1994-03-17
K933295 MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA Medic, Inc. LNH Class II 1994-03-17
K935664 FAST SPIN ECHO Hitachi Medical Systems America, Inc. LNH Class II 1994-03-16
K933558 ARM RADIATION BEAM SCANNER Advanced Radiation Measurements, Inc. IYE Class II 1994-03-16
K932564 RADSTAT Dimensional Medicine, Inc. LLZ Class II 1994-03-16
K940294 SHIMADZU MOBILE X-RAY SYSTEMS Shimadzu Precision Instruments, Inc. OXO Class II 1994-03-16
K940539 STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM Standard Imaging, Inc. KPY Class I 1994-03-16
K935661 MAGNETOM OPEN Siemens Medical Solutions USA, Inc. LNH Class II 1994-03-16
K935580 PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER Precise Optics OXO Class II 1994-03-16
K936180 TC+ SYSTEM (TILTING C-ARM SYSTEM) GE Medical Systems OWB Class II 1994-03-16
K934700 MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY Tempo Technology, Inc. OXO Class II 1994-03-16
K940696 SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 Philips Medical Systems North America, Inc. KXJ Class II 1994-03-16
K931393 BEBIG PLAQUES RUM101-RUM114 Bebig, Inc. KXK Class II 1994-03-16
K935570 NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM Resonex, Inc. LNH Class II 1994-03-16
K930768 ORION DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems IYO Class II 1994-03-15
K935694 SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE Siemens Medical Solutions USA, Inc. LLZ Class II 1994-03-07
K934574 MODEL MPFT-01, GENESIS International Medical Designs, Inc. IXR Class II 1994-03-04
K931460 VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM General Electric Co. LNH Class II 1994-03-04
K935318 SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS Summit Nuclear KPS Class II 1994-02-25
K932403 AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN Medrad, Inc. LNH Class II 1994-02-24
K934459 MED-GENESIS PATIENT LASER EYE SHIELD Med-Genesis, Inc. IWS Class I 1994-02-22
K934549 ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD Victoreen, Inc. IWR Class I 1994-02-19
K933018 MRT-50GP Toshiba America Mri, Inc. LNH Class II 1994-02-18
K934766 CARBON FIBER PALLET Siemens Gammasonics, Inc. IYX Class I 1994-02-18
K935539 CAPINTEC CRC 35R Capintec Instruments, Inc. KPT Class II 1994-02-18
K932371 CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWARE Cemax, Inc. LLZ Class II 1994-02-18
K925799 AD/V A.5 Adaptive Video, Inc. LMA Class II 1994-02-18
K932673 APEX SPX CARDIAL Elscint, Inc. IYX Class I 1994-02-18
K931410 NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM Novus Technologies, Inc. LMB Class I 1994-02-18
K932244 SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM Shimadzu Medical Systems LNH Class II 1994-02-18
K931483 REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. Portable Power Systems, Inc. IZL Class II 1994-02-17
K934949 DIGORA Orion Corporation Soredex IXK Class II 1994-02-10
K930278 STORZ COMPUSCAN AB Storz IYO Class II 1994-02-09
K930124 VARIANT OF OCTOSTOP AND OCTOPAQUE Octostop, Inc. KXH Class I 1994-02-09
K935103 VISIONLINK ACR-NEMA CONVERSION UTILITIES Evergreen Technologies, Inc. LMD Class I 1994-02-09
K932552 SPORTS MEDICINE QUADRATURE SHOULDER COIL Magnetic Research, Inc. LNH Class II 1994-02-09
K931293 SSH-140A FETAL DOPPLER SYSTEM Toshiba America Medical Systems, In.C IYN Class II 1994-02-09
K935084 INCREASED SAR PACKAGE FOR MRT-150A Toshiba America Mri, Inc. LNH Class II 1994-02-09
K935649 WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY Bennett X-Ray Corp. KPR Class II 1994-02-09
K933472 SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES Shimadzu Corp. JAA Class II 1994-02-07
K932353 HF-110A Dynarad Corp. IZL Class II 1994-01-31
K934870 LORAD D-550 Lorad Corp. IZH Class II 1994-01-31
K934748 LORAD M-IIE MODIFICATION Lorad Corp. IZH Class II 1994-01-31
K935957 FUJI MEDICAL FILM PROCESSOR FPM2800 Fujifilm Medical System U.S.A., Inc. IXW Class II 1994-01-31
K934625 LORAD M-III Lorad Corp. IZH Class II 1994-01-28
K934908 FULL VIEW DIGITAL STORAGE SYSTEM International Imaging Electronics IYO Class II 1994-01-28
K934889 OLYMPUS IMAGEMANAGER SYSTEM Olympus LMB Class I 1994-01-28
K935760 TEC 2100 (MODEL MT-LPLGD) Medtec, Inc. IWE Class I 1994-01-25
K930708 PHILIPS GYROSCAN T5 II RELEASE 3 Philips Medical Systems, Inc. LNH Class II 1994-01-25
K934485 HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION Hitachi Medical Systems America, Inc. LNH Class II 1994-01-25
K934888 OLYMPUS IMAGEMANAGERSYSTEM Olympus LMB Class I 1994-01-25
K936136 UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE Ge Dec Medical Systems JAA Class II 1994-01-25
K934818 HAND HELD DENTAL X-RAY DEVICE Dept. of the Army IZL Class II 1994-01-24
K933663 MODIFICATION OF ACUSON V510B TRANSDUCER Acuson Corp. ITX Class II 1994-01-21
K931298 SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM General Electric Co. LNH Class II 1994-01-18
K932271 MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016 Siemens Medical Solutions USA, Inc. LNH Class II 1994-01-07
K925869 SHEATHES, STERILE SHEATHES Mayer Laboratories ITX Class II 1994-01-06
K934386 IMPAX 5000 Heraeus Kulzer, Inc. LMD Class I 1994-01-05
K930182 RADIATION TREATMENT FOR CANCER PATIENTS Northwest Medical Physics Center IYE Class II 1994-01-05
K934719 EXTRA LARGE QUAD FLEX SPINE COIL Hitachi Medical Systems America, Inc. LNH Class II 1994-01-05
K930500 MAXIVIEW DIAGNOSTIC WORKSTATION Dimensional Medicine, Inc. LMD Class I 1993-12-29
K934212 FAST SPIN ECHO Hitachi Medical Systems America, Inc. LNH Class II 1993-12-27
K934499 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE Medical Systems LNH Class II 1993-12-23
K934944 MPQ-42 Elema-Schonander, Inc. IZP Class II 1993-12-15
K933664 POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) Siemens Gammasonics, Inc. IZI Class II 1993-12-15
K935397 NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS Victoreen, Inc. IXA Class II 1993-12-15
K931454 IMAGEACCESS SYSTEM Image Premastering Services, Inc. LNH Class II 1993-12-14
K933830 KONICA LD-4500 LASER DIGITIZER Konica Medical Corp. LMA Class II 1993-12-14
K931656 MERIT Picker International LNH Class II 1993-12-14
K931316 KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR Konica Medical Corp. IXW Class II 1993-12-14
K933356 MERIT Philips Medical Systems (Cleveland), Inc. LNH Class II 1993-12-14
K932091 PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL Magnetic Research, Inc. LNH Class II 1993-12-14
K931317 KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR Konica Medical Corp. IXW Class II 1993-12-14
K934832 IMPAX 3000 Heraeus Kulzer, Inc. JAK Class II 1993-12-14
K931315 KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR Konica Medical Corp. IXW Class II 1993-12-14
K923697 RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U Radionics, Inc. KXK Class II 1993-12-13
K934496 X-RAY ANGIOGRAPHIC SYSTEM Camtronics, Ltd. IZI Class II 1993-12-13
K934967 SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR Shimadzu Corp. IZO Class I 1993-12-13

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