meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
32
Latest Decision
1997-07-03

Clearances · page 105 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971279 VERSION 4 OPERATING SYSTEM SOFTWARE Hitachi Medical Systems America, Inc. LNH Class II 1997-07-03
K971380 MEDRAD FLEX INTERFACE DEVICE Medrad, Inc. LNH Class II 1997-07-03
K971347 MEDISURF International Regulatory Consultants LMD Class I 1997-07-03
K965179 INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO Neo Imagery Technologies, Inc. LLZ Class II 1997-07-03
K964606 THERATRON 780E Theratronics, Inc. IWB Class II 1997-06-26
K971167 NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES Neoprobe Corp. IZD Class I 1997-06-26
K964969 SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) GE Medical Systems MOS Class II 1997-06-26
K972136 TV MONITOR (P12/17) Perkins Mfg. Co. IZI Class II 1997-06-26
K971368 IDS4 IMAGE DISPLAY SYSTEM SERIES O Tech, Inc. LLZ Class II 1997-06-26
K971451 WISE IMAGE MANAGEMENT SYSTEM O Tech, Inc. LMB Class I 1997-06-26
K971153 SPLITSCREEN (ME-975) Merlin Engineering Works, Inc. LMD Class I 1997-06-25
K971154 MULTIPICS(ME-977) Merlin Engineering Works, Inc. LMD Class I 1997-06-25
K964947 PHOTON RADIOSURGERY SYSTEM (PRS) Photoelectron Corporation JAD Class II 1997-06-20
K971714 NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO National Data Corp. LLZ Class II 1997-06-20
K970513 GENERAL PURPOSE TRANDUCER COVER CIVCO Medical Instruments Co., Inc. ITX Class II 1997-06-20
K970049 BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ Cardiovascular Imaging Systems, Inc. ITX Class II 1997-06-20
K970514 DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE CIVCO Medical Instruments Co., Inc. ITX Class II 1997-06-20
K971290 STRATASYS FDM MEDMODELER SYSTEM Paladin Medical, Inc. LLZ Class II 1997-06-20
K971055 DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION Siemens Medical Solutions USA, Inc. LNH Class II 1997-06-20
K971246 LEO 7000 QUADRATURE KNEE COIL Usa Instruments, Inc. MOS Class II 1997-06-20
K970515 GENERAL PURPOSE LATEX TRANSDUCER COVERS CIVCO Medical Instruments Co., Inc. ITX Class II 1997-06-20
K964206 NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2 Nucletron Corp. IYE Class II 1997-06-20
K970680 GLORY Elscint, Inc. IZH Class II 1997-06-20
K965044 GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 Elscint, Inc. LNH Class II 1997-06-16
K971115 GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE Protek Medical Products, Inc. ITX Class II 1997-06-13
K970970 CARDIOMATCH Focus Medical SA KPS Class II 1997-06-13
K961787 BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS Hologic, Inc. KGI Class II 1997-06-13
K971001 AUTIMO Medizintechnik, GmbH IXI Class II 1997-06-13
K971054 OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS Siemens Medical Solutions USA, Inc. JAK Class II 1997-06-13
K964025 MITAYA ALUMINUM INTERSPACED X-RAY GRID X-Ray Accessory Corp. IXJ Class I 1997-06-13
K964785 VERIDOSE DIODES Victoreen, Inc. IYE Class II 1997-06-13
K971074 THERAPAX SXT 150 Pantak, Inc. JAD Class II 1997-06-13
K970964 MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM International Imaging Electronics LLZ Class II 1997-06-13
K971382 PRONE BREAST POSITIONING BOARD, MODEL #37-018 Victoreen, Inc. IYE Class II 1997-06-06
K971016 MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) Hitachi Medical Systems America, Inc. MOS Class II 1997-06-06
K970868 MODEL HNC NEUROVASCULAR ARRAY COIL Mri Devices Corp. MOS Class II 1997-06-06
K970852 MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE) Siemens Medical Solutions USA, Inc. LNH Class II 1997-06-05
K964549 ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER Aloka Co., Ltd. ITX Class II 1997-06-03
K962142 SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYO Class II 1997-05-29
K970980 CARDIAC SCORING FOR CT SCANNERS Elscint, Inc. JAK Class II 1997-05-29
K963068 CTS-200 WITH EZU-PL21 TRANSDUCER Shantou Institute of Ultrasonic Instuments IYO Class II 1997-05-29
K961229 HR12000 ULTRASOUND SYSTEM International Ultrasound Corp. IYO Class II 1997-05-29
K963065 CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS Shantou Institute of Ultrasonic Instuments IYO Class II 1997-05-29
K964438 511 KEV COLLIMATOR Trionix Research Laboratory, Inc. KPS Class II 1997-05-29
K963990 GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES Philips Medical Systems, Inc. LNH Class II 1997-05-29
K964607 THERATON 1000E Theratronics, Inc. IWD Class II 1997-05-28
K961104 NOTEBOOK IMAGER Digirad Corp. IYX Class I 1997-05-28
K970647 OUR ROTATING GAMMA SYSTEM Our Scientific Intl., Inc. IWB Class II 1997-05-20
K970999 SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR Sony Medical Systems JAK Class II 1997-05-20
K971431 UMI X-RAY FILM CASSETTE Umi Intl. IXA Class II 1997-05-20
K970908 HOWTEK 960 Howtek, Inc. LMA Class II 1997-05-20
K970947 B-350 CEILING MOUNTED C-POSITIONER Omega Medical Imaging, Inc. JAA Class II 1997-05-14
K971452 MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE Siemens Medical Solutions USA, Inc. IZZ Class II 1997-05-14
K971365 PHILIPS INTEGRIS H5000 Philips Medical Systems North America, Inc. IZI Class II 1997-05-14
K970564 DYNAMIC WEDGE Mitsubishi Electronics America, Inc. IYE Class II 1997-05-12
K970586 BRAINLAB MICRO MULTI-LEAF COLLIMATOR Brainlab Med. Computersysteme GmbH IYE Class II 1997-05-12
K970628 GE ADVANTAGE DIGITIZER WORKSTATION Ge Medical Systems, Inc. LMD Class I 1997-05-12
K970813 DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 Denvu, Inc. LLZ Class II 1997-05-08
K964069 DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM Siemens Medical Solutions USA, Inc. IZH Class II 1997-05-08
K970738 KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT Jamieson Film Co. IZI Class II 1997-05-07
K954220 EUB-8000 Hitachi Medical Corp. of America IYN Class II 1997-05-07
K964972 SHADOWFORM I.Z.I. Medical Products Corp. KPQ Class II 1997-05-05
K970641 RIS SCANVIEW SYSTEM (RSVS) Radiology Information Systems, Inc. LMD Class I 1997-05-02
K970652 MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE Mitra Imaging, Inc. LMD Class I 1997-05-02
K970234 SEALED LEAD ACID BATTERY PACK Portable Power Systems, Inc. IZL Class II 1997-05-02
K970174 FREEPIX/PIXPACS DICOM/HTTP GATEWAY Pixelinks, Inc. LMD Class I 1997-05-01
K970623 IMMERGE IMAGE CORRELATION Surgical Navigation Technologies, Inc. LLZ Class II 1997-04-28
K971128 CAP-35B III/CINE 275 Jamieson Film Co. IXR Class II 1997-04-28
K970303 SATURNE MULTILEAF COLLIMATOR General Electric Co. IXI Class II 1997-04-25
K970288 CLINICAL DIAGNOSTIC SOFTWARE Nuccardiac Software, Inc. KPS Class II 1997-04-24
K970291 ACCESSORIES TO THE STEREOTACTIC BODY FRAM Elekta Instrument AB IYE Class II 1997-04-24
K963989 P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE Cardiovascular Dynamics, Inc. ITX Class II 1997-04-24
K962882 SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYO Class II 1997-04-24
K964288 CALL-RAD PC TELERADIOLOGY Pc Teleradiology LMA Class II 1997-04-23
K964309 SONOS 2000, SONOS 2500 (M2406 A) Hewlett-Packard Co. IYN Class II 1997-04-22
K970617 CT-MODELLER SYSTEM Materialise NV LLZ Class II 1997-04-21
K970734 SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS Siemens Medical Solutions USA, Inc. OWB Class II 1997-04-21
K963863 JANUS I 3D Ultrasound, Inc. IYO Class II 1997-04-21
K970608 EVT MARKER BOARD Guidant Cardiac and Vascular Surgery JAA Class II 1997-04-21
K970090 SOLO-SLED Solo-Sled, LLC IXA Class II 1997-04-21
K970525 STATNET Gorca Systems, Inc. IZI Class II 1997-04-16
K964307 EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS Lunar Corp. KGI Class II 1997-04-16
K970224 PIXI BONE DENSITOMETER Lunar Corp. KGI Class II 1997-04-16
K960421 SINUSCAN 102/SINUSPRINT Ferguson Medical LWI Class II 1997-04-16
K970137 EXL-12SP,12DP,15DP,20DP LINAC Mitsubishi Electronics America, Inc. IYE Class II 1997-04-15
K970128 ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA) Park Medical Systems, Inc. KPS Class II 1997-04-11
K970451 DOWNSCAN 120 Merlin Engineering Works, Inc. LLZ Class II 1997-04-07
K970534 PICTURE ARCHIVING & COMMUNICATIONS DEVICE Multimedia Solutions LLZ Class II 1997-04-04
K970154 KODAK EKTASIAN HG FILM (EHG-15) Eastman Kodak Company IWZ Class I 1997-04-04
K970156 IMEX FUTURALDOP PRO Imex Medical Systems, Inc. IYO Class II 1997-04-04
K970606 COMPUTED TOMOGRAPHY X-RAY SYSTEM GE Medical Systems JAK Class II 1997-04-04
K963616 ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 1997-04-03
K962627 CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM Siemens Medical Solutions USA, Inc. LNI Class II 1997-04-03
K964517 LINAC SCALPEL FLOORSTAND Surgical Navigation Technologies, Inc. IYE Class II 1997-04-01
K970450 UPSCAN 120 Merlin Engineering Works, Inc. LLZ Class II 1997-04-01
K963936 ACCESSPOINT, MED E-MAIL, DICOM READER Biosound, Inc. LMB Class I 1997-03-31
K970349 FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667 Fujifilm Medical System U.S.A., Inc. LLZ Class II 1997-03-31
K963983 E. CAM PROFILE ATTENUATION CORRECTION Siemens Corp. KPS Class II 1997-03-31
K970005 GYREX 2T-PRESTIGE Elscint, Inc. LNI Class II 1997-03-28
K963262 ARTOSCAN M Biosound, Inc. LNH Class II 1997-03-28

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