meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
35
Latest Decision
1995-02-15

Clearances · page 113 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945383 HIGH DOSE RATE AFTERLOADER Varian Assoc., Inc. JAQ Class II 1995-02-15
K950037 N 800 HF Oldelft Corp. of America IZO Class I 1995-02-15
K946262 EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES Scott Imaging Intl., Inc. IXQ Class II 1995-02-15
K946261 MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 Scott Imaging Intl., Inc. IYB Class I 1995-02-15
K940412 MULTILEAF INTENSITY MODULATING COLLIMATOR Nomos Corp. IXI Class II 1995-02-15
K945731 HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS Bennett X-Ray Corp. IZO Class I 1995-02-15
K942580 NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES Neoprobe Corp. IZD Class I 1995-02-09
K943109 REMOTE CONTROL RADIOISOTOPE APPLICATOR Inter-Pal GmbH JAQ Class II 1995-02-09
K945397 ANGIO II Philips Medical Systems (Cleveland), Inc. LNH Class II 1995-02-09
K945682 PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL Gendex Corp. EGY Class II 1995-02-09
K941927 THE NOMOS CRANE Nomos Corp. JAI Class II 1995-02-09
K932356 NOVA XM2 Dynarad Corp. IZH Class II 1995-02-08
K934523 GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1) Radionics, Inc. IYE Class II 1995-02-08
K944816 SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) Philips Medical Systems (Cleveland), Inc. IZH Class II 1995-02-08
K950317 ADVANTX 1824 SPOTFILM DEVICE GE Medical Systems IXL Class II 1995-02-08
K946244 ACCESS(TM) COMPASS BED Toshiba America Mri, Inc. LNH Class II 1995-02-08
K945389 IVR MASTER Shimadzu Corp. LLZ Class II 1995-02-07
K944013 CT PROSPEED FAMILY GE Medical Systems JAK Class II 1995-02-07
K925964 IMAGE TRANSPORT SERIES III Dataview Imaging Intl., Inc. LMD Class I 1995-02-03
K943545 CEILING SUSPENDED C-ARM SUPPORT MH-100 Shimadzu Medical Systems IZI Class II 1995-02-03
K925963 IMAGE TRANSPORT SERIES II Dataview Imaging Intl., Inc. LLZ Class II 1995-02-03
K930458 MULTI-DOP L Dantec Medical, Inc. IYN Class II 1995-02-03
K943303 PVK-357AT Toshiba America Medical Systems, In.C IYO Class II 1995-02-03
K942669 SMT-50CX/H Shimadzu Medical Systems LNH Class II 1995-02-02
K945635 TRANS X-1000 Canon USA, Inc. KPX Class II 1995-02-01
K943464 PHILIPS IMPROVED CHECK RADIOGRAPH OPTION Philips Medical Systems North America, Inc. IYE Class II 1995-02-01
K931996 MODEL PDEXA BONE DENSITOMETER Norland Corp. KGI Class II 1995-02-01
K942019 MODEL FP-100 International Medical Designs, Inc. JAA Class II 1995-02-01
K940859 PACSPRO I Advanced Video Products, Inc. LMD Class I 1995-02-01
K943113 SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYO Class II 1995-02-01
K945697 SK S-RAY GRIDS Seibu Techno Coproration IXJ Class I 1995-01-31
K934478 ALPHA STEREO Instrumentarium Corp. IZH Class II 1995-01-31
K945375 ADVANTX LCA GE Medical Systems IZI Class II 1995-01-30
K945459 DLX General Electric Co. IZI Class II 1995-01-30
K945388 DFS-700 Shimadzu Corp. LLZ Class II 1995-01-30
K945580 DSP OPTION Philips Medical Systems (Cleveland), Inc. IZJ Class II 1995-01-30
K944771 INTRASCAN II Markcare Medical Systems, Inc. LMD Class I 1995-01-26
K941622 ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION Siemens Medical Solutions USA, Inc. LNH Class II 1995-01-26
K941864 MRT-150A, MRT-150A SOFTWARE VERSION 11.9 Toshiba America Mri, Inc. LNH Class II 1995-01-26
K934139 TOMTEC ECHO-VIEW Tomtec Tomographic Technologies GmbH IYO Class II 1995-01-25
K944469 GENERAL PURPOSE FLEX COIL Philips Medical Systems (Cleveland), Inc. LNH Class II 1995-01-25
K944331 MODEL 528GE SERIES Medical Advances, Inc. LNH Class II 1995-01-25
K944773 MODEL 405GE-64: PHASED ARRAY TMJ COIL Medical Advances, Inc. LNH Class II 1995-01-25
K944131 ANATOM 2000 Analogic Corp. JAK Class II 1995-01-25
K944662 FLEXART QD BODY COIL Toshiba America Mri, Inc. LNH Class II 1995-01-25
K940145 COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE Huestis Machine Corp. IYE Class II 1995-01-24
K945043 BATTERY PACK #PMX120-18A Portable Power Systems, Inc. IZL Class II 1995-01-20
K945328 JPI X-RAY FILM CASSETTE Jpi America, Inc. IXA Class II 1995-01-20
K945327 JPI X-RAY GRID Jpi America, Inc. IXJ Class I 1995-01-20
K943505 HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER Hologic, Inc. KGI Class II 1995-01-20
K945707 MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT Minxray, Inc. IZL Class II 1995-01-19
K944613 SHOULDER RETRACTOR Northwest Medical Physics Center KPR Class II 1995-01-18
K945842 MOBILIX MOBILE X-RAY TABLE GE Medical Systems IXR Class II 1995-01-18
K942837 DST-XL Sopha Medical Systems, Inc. KPS Class II 1995-01-05
K945293 TOP ACOM STATION Siemens Medical Solutions USA, Inc. IZI Class II 1995-01-05
K930052 SIEMENS QUANTUM 7E11 TRANSRECTAL TRANSDUCER Siemens Quantum, Inc. ITX Class II 1995-01-04
K943581 HYDRADJUST IV UROLOGICAL TABLE Mallinckrodt Group, Inc. IXR Class II 1995-01-04
K940119 ROYAL MARSDEN GOLD GRAIN GUN Best Industries IWS Class I 1994-12-30
K940121 IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS Best Industries IWJ Class I 1994-12-30
K933410 IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES Best Industries IWJ Class I 1994-12-30
K943800 2D,3D, TOF MR ANGIOGRAPHY Hitachi Medical Systems America, Inc. LNH Class II 1994-12-30
K943637 SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. ITX Class II 1994-12-29
K943863 NEEDLE GUIDE Biopsys Medical, Inc. IYN Class II 1994-12-29
K945668 KXO-80G Toshiba America Medical Systems, In.C IZO Class I 1994-12-27
K945496 MAMMOGRAPHIC X-RAY UNIT Lorad Corp. IZH Class II 1994-12-27
K943272 VISUALIZER 2000 Vf-Works, Inc. JAA Class II 1994-12-27
K925582 MEDISON 4800 Medison America, Inc. IYO Class II 1994-12-27
K923273 AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM Acoustic Imaging Technologies Corp. IYO Class II 1994-12-27
K943011 TUNGSTEN EYESHIELD Medtec, Inc. IWS Class I 1994-12-23
K942561 FUJI FCR IMAGE PROCESSING UNIT IP-U515 Fujifilm Medical System U.S.A., Inc. IXK Class II 1994-12-23
K943343 FIELD ABUTMENT WEDGE Medtec, Inc. IXI Class II 1994-12-23
K944720 COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION Nuccardiac Software, Inc. KPS Class II 1994-12-23
K944130 RIT 531 TELERADIOLOGY/ PAC SYSTEM Radiological Imaging Technology, Inc. LMD Class I 1994-12-23
K941582 SUPERSENSOR MRI COIL Superconductor Technologies, Inc. LNH Class II 1994-12-23
K944112 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE Medical Systems LNH Class II 1994-12-22
K944523 HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER Humphrey, Inc. IYO Class II 1994-12-15
K943406 RF DRIVER, RADIO FREQUENCY DRIVER Pro-Comm, Inc. IYE Class II 1994-12-15
K943415 MERIT (O.1T MR SYSTEM) Philips Medical Systems (Cleveland), Inc. LNH Class II 1994-12-15
K934572 UNITONE Scitex Corporation , Ltd. LLZ Class II 1994-12-15
K945238 MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 F. Walter Hanel GmbH IWQ Class I 1994-12-15
K944973 NRF SYSTEM Philips Medical Systems (Cleveland), Inc. JAA Class II 1994-12-14
K945278 PHILIPS BUCKY DIAGNOST FAMILY Philips Medical Systems North America, Inc. KPR Class II 1994-12-14
K945272 RHODIUM FILTER Lorad Corp. IZH Class II 1994-12-14
K945709 SII 525 MS Scott Imaging Intl., Inc. KPR Class II 1994-12-14
K945708 SII 360 MS Scott Imaging Intl., Inc. KPR Class II 1994-12-14
K942581 BES - BREATH EXPOSURE SYNCHRONIZER The Henry G. Dietz Co., Inc. KPR Class II 1994-12-12
K941224 LENZAR REMOTE ACQUISITION SYSTEM Lenzar Electrooptics, Inc. LMD Class I 1994-12-09
K940660 MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM Victoreen, Inc. IYE Class II 1994-12-09
K944967 TOMO-LINK GE Medical Systems IZF Class II 1994-12-09
K943799 VERSION 5 OPERATING SYSTEM SOFTWARE Hitachi Medical Systems America, Inc. LNH Class II 1994-12-09
K945483 COMPAS General Electric Co. IZI Class II 1994-12-09
K935923 PHILIPS ULTRASOUND P800 IMAGING SYSTEM Hewlett-Packard Co. IYN Class II 1994-12-08
K942874 MODEL #300TO3500 SHOULDER COIL Medic, Inc. LNH Class II 1994-12-08
K942861 MEDVISION ENVIROMENT/MEDVISION 2.0 Evergreen Technologies, Inc. LMD Class I 1994-12-07
K943802 HP BACK POINTER SYSTEM Medtec, Inc. IWE Class I 1994-12-07
K943199 MOTORIZED DEPTH DOSE APPARATUS Medtec, Inc. IYE Class II 1994-12-07
K940108 DIAGNOSTIC ULTRASOUND IMAGING CATHETER Boston Scientific Corp ITX Class II 1994-12-07
K943532 PANORAMIC CORPORATION HDLX Panoramic Corp. JAA Class II 1994-12-07
K942875 MODEL #900TO3500 HEAD/NECK COIL Medic, Inc. LNH Class II 1994-12-02
K942873 MODEL #700TO3500 NECK/ABDOMINAL COIL Medic, Inc. LNH Class II 1994-12-02

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