meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
29
Latest Decision
1994-08-17

Clearances · page 115 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K941979 VIDEO PLUS WITH ANALYTICAL WORKSTATION Camtronics, Ltd. IZI Class II 1994-08-17
K933320 CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT Cardio Metrics, Inc. IYO Class II 1994-08-17
K943425 FUJI HG-M INTENSIFYING SCREEN Fujifilm Medical System U.S.A., Inc. EAM Class I 1994-08-17
K940386 KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP Eastman Kodak Company IXL Class II 1994-08-17
K940550 COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH Cook, Inc. IWJ Class I 1994-08-17
K942235 KYOKKO GREEN SERIES INTENSIFYING SCREENS Fujifilm Medical System U.S.A., Inc. EAM Class I 1994-08-17
K941812 SLICES Microsignal Corp. LNH Class II 1994-08-12
K934303 RFA A-300 Scanditronix, Inc. IYE Class II 1994-08-09
K926321 VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D) Varian Assoc., Inc. IYE Class II 1994-08-09
K943381 LASER ALIGNMENT TOOL Philips Medical Systems North America, Inc. IWE Class I 1994-08-09
K935157 ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES Regulatory Consultants TO the Medical Device Indus KPX Class II 1994-08-09
K942841 OEC 901 Baldwin JAA Class II 1994-08-09
K935691 MODEL GP-252 GENERAL PURPOSE COIL Diagnostic Instrument Corp. LNH Class II 1994-08-01
K942116 SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER) Siemens Corp. KPS Class II 1994-07-29
K942805 KYOKKO BLUE SERIES INTENSIFYING SCREENS Fujifilm Medical System U.S.A., Inc. EAM Class I 1994-07-29
K942909 KODAK INSIGHT TWIN-LOAD INSERT Eastman Kodak Company EAM Class I 1994-07-29
K935928 RIT 113 FILM ANALYSIS SYSTEM Radiological Imaging Technology, Inc. IYE Class II 1994-07-29
K935435 NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST Victoreen, Inc. IYE Class II 1994-07-29
K942792 BUCKY STAND BR-10M Shimadzu Corp. KPR Class II 1994-07-29
K942481 FUJI ULTIMA EC-MA CASSETTE Fujifilm Medical System U.S.A., Inc. IXA Class II 1994-07-29
K941933 ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW) I.S.G. Technologies, Inc. LLZ Class II 1994-07-29
K941017 F/C/W TUBESTAND Acoma Medical Imaging, Inc. IYB Class I 1994-07-29
K941745 TSX-002A (XVISION) CT SCANNER Toshiba America Medical Systems, In.C JAK Class II 1994-07-29
K932508 ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW Elscint, Inc. JAK Class II 1994-07-29
K940423 NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE Advanced Technology Laboratories, Inc. LMD Class I 1994-07-29
K942674 ANGIOREST TABLE PAD SYSTEM Scribner Browne Medical Design, Inc. JAA Class II 1994-07-29
K941004 CTS SYSTEM Acoma Medical Imaging, Inc. IYB Class I 1994-07-29
K942092 DPD-3 Scanditronix, Inc. IYE Class II 1994-07-29
K942778 MODEL VPW2877F8, MAMMO 5 POWER SUPPLY Varian Assoc., Inc. IZO Class I 1994-07-29
K941408 MERIT Philips Medical Systems (Cleveland), Inc. LNH Class II 1994-07-28
K940237 THERAPLAN V05B/ TP-11 V09B Theratronics, Inc. IYE Class II 1994-07-26
K934657 BRAINLAB LINAC HARDWARE Brainlab Med. Computersysteme GmbH IYE Class II 1994-07-22
K942264 DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) Eigen Video JAA Class II 1994-07-20
K941363 PHANTOM Dynarad Corp. IZL Class II 1994-07-20
K942503 UNICATH FAMILY Angiographic Devices Corp. IZI Class II 1994-07-20
K941475 CRONEX REGULAR CASSETTE Dupont Medical Products IXA Class II 1994-07-20
K942282 MED-TEC BREAST SUPPORT SYSTEM Medtec, Inc. IYE Class II 1994-07-18
K940540 VELO ACE Emix U.S.A., Inc. IXW Class II 1994-07-18
K933227 UNI-FRAME HEAD IMMOBILIZATION SYSTEM Medtec, Inc. IYE Class II 1994-07-18
K935412 MED-TEC, INC. BREAST BOARD, MT-200 Medtec, Inc. IYE Class II 1994-07-18
K935411 MED-TEC, INC. BREAST BOARD, MT-250 Medtec, Inc. IYE Class II 1994-07-18
K935300 VAC-LOK IMMOBILIZATION SYSTEM Medtec, Inc. IYE Class II 1994-07-18
K942120 ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION GE Medical Systems IZI Class II 1994-07-18
K941169 TEC 2101 (MODEL MT-HPLGD) Medtec, Inc. IWE Class I 1994-07-18
K941719 360 DEG. ROTATING 1/2 BEAM BLOCK Medtec, Inc. IXI Class II 1994-07-18
K942040 MRX-280 Mrx Corp. JAK Class II 1994-07-05
K935487 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF Shimadzu Corp. JAK Class II 1994-07-05
K926332 DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED B&K Medical IYO Class II 1994-06-28
K941203 MEDICAL IMAGING WORKSTATION II (MIW II) Cemco, Inc. LMD Class I 1994-06-27
K933202 VENUS DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems IYN Class II 1994-06-27
K941086 PACSPRO II Advanced Video Products, Inc. LMD Class I 1994-06-27
K935224 VOLUME NECK COIL FOR THE GYREX V-DIX Elscint, Inc. LNH Class II 1994-06-27
K933056 DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED B&K Medical IYO Class II 1994-06-24
K930193 PHILIPS ENDO-CAVITARY MRI COIL Philips Medical Systems, Inc. LNH Class II 1994-06-24
K934205 SEARCH-SONIC Altana, Inc. IYO Class II 1994-06-21
K940364 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY Medical Advances, Inc. LNH Class II 1994-06-21
K934514 CATCH AND HOLD OPTION FOR INSTASCAN Advanced Nmr Systems, Inc. LNH Class II 1994-06-21
K942399 KYOKKO UM SERIES INTENSIFYING SCREEN Fujifilm Medical System U.S.A., Inc. EAM Class I 1994-06-10
K940804 SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION Peripheral Systems Group ITX Class II 1994-06-10
K940442 MPR-814 Xri, Inc. IYB Class I 1994-06-09
K940332 MODEL FORTY ULTRA COMPACT VIDEO IMAGER International Imaging Electronics LMC Class II 1994-06-08
K940408 REMOTE CONSOLE Robinson Engineering Teleradiology System LMD Class I 1994-06-08
K941025 PHASED ARRAY BREAST COIL Medical Advances, Inc. LNH Class II 1994-06-08
K942100 MODEL TM EP HIGH VOLTAGE GENERATOR Continental X-Ray Corp. IZO Class I 1994-06-07
K942367 AXT 1400 SPOTFILM DEVICE Applied X-Ray Technologies, Inc. IXL Class II 1994-06-06
K941177 ANGIOREX CAS-05A Toshiba America Medical Systems, In.C IZI Class II 1994-06-06
K941592 WEIGHT BAG Biocor, Inc. KPR Class II 1994-06-06
K941518 DUPONT CRONEX PORTABLE GRID CASSETTE Dupont Medical Products IXA Class II 1994-06-06
K940874 MODEL 900GE1500 HEAD/NECK COIL Medic, Inc. LNH Class II 1994-06-03
K932598 TN-RD-50 Keithley Instruments, Inc. IYE Class II 1994-06-03
K926209 EUB-555 Hitachi Medical Corp. IYO Class II 1994-06-03
K935067 AQUAPLAST Wfr/Aquaplast Corp. IYE Class II 1994-05-26
K934686 MOLYBDENUM/RHODIUM FILTERS Continental X-Ray Corp. IZO Class I 1994-05-26
K941931 DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR Victoreen, Inc. KPR Class II 1994-05-26
K922276 THERAC 25 Theratronics, Inc. IYE Class II 1994-05-25
K940602 EXTRA LARGE QUAD FLEX SPINE COIL Hitachi Medical Systems America, Inc. LNH Class II 1994-05-23
K936153 3M 1156 MULTI-INPUT SYSTEM 3M Information,Imaging and Electronic Sector LMD Class I 1994-05-23
K941946 LCA ANGIOGRAPHIC IMAGING SYSTEM GE Medical Systems IZI Class II 1994-05-20
K935608 MAMOSPAT E.V.S. Tool & Die Co., Inc. IZH Class II 1994-05-17
K923524 VOLUMETRIC RENDERING TECHNIQUE OPTION Siemens Medical Solutions USA, Inc. JAK Class II 1994-05-17
K941611 TDA-4000/A4 Toshiba America Medical Systems, In.C JAA Class II 1994-05-13
K934722 PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION Ohio Imaging, Inc. KPS Class II 1994-05-13
K941626 GRIDGIL Gilardoni S.P.A. IXJ Class I 1994-05-13
K933747 CAPASEE Toshiba America Medical Systems, In.C IYO Class II 1994-05-13
K935015 QUADRATURE SMALL EXTREMITY COIL Magnetic Research, Inc. LNH Class II 1994-05-10
K926560 EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER Fischer Imaging Corp. JAA Class II 1994-05-09
K940514 41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15 Medical Advances, Inc. LNH Class II 1994-05-05
K936161 SYSTEM, X-RAY, MAMOGRAPHIC Technowipe IZH Class II 1994-05-04
K940236 QUANTITATIVE HEART Siemens Medical Solutions USA, Inc. KPS Class II 1994-05-03
K915403 DIAGNOSTIC ULTRASOUND SYSTEM Hitachi Medical Systems America, Inc. IYN Class II 1994-05-03
K940721 CLINIX VP 4 TABLE Philips Medical Systems (Cleveland), Inc. IXR Class II 1994-05-03
K936116 KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS Eastman Kodak Company LMD Class I 1994-04-29
K921219 PHILIPS DCI-SX Philips Medical Systems, Inc. OWB Class II 1994-04-29
K940285 ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION Acuson Corp. IYN Class II 1994-04-29
K940701 BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH Bennett X-Ray Corp. IZH Class II 1994-04-28
K940227 SCPU X-RAY GENERATOR General Electric Co. IZO Class I 1994-04-28
K934538 MRI RESONANCE DIAGNOSTIC DEVICE ACCESORY Noise Cancellation Technologies LNH Class II 1994-04-25
K940309 X-RAY GRID (RADIOLOGICAL GRID) J.P.I. Chicago Co. IXJ Class I 1994-04-22
K940484 COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. IZI Class II 1994-04-19
K935273 VISION FX 40 & 80 SERIES GAMMA CAMERA Summit Nuclear IYX Class I 1994-04-18

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