meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
29
Latest Decision
1997-10-28

Clearances · page 104 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K972905 XPLAN-1 Radionics Software Applications, Inc. IYE Class II 1997-10-28
K973422 LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) Dejarnette Research Systems LMC Class II 1997-10-28
K973090 MEDSTATION Program S.R.L. LMD Class I 1997-10-28
K972271 NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A Ml Strategies, Inc. KXK Class II 1997-10-28
K973028 HELIOS LASER IMAGER 1417 Sterling Diagnostic Imaging, Inc. LMC Class II 1997-10-28
K972933 VOX/BASE FOR WINDOWS J-Mac System, Inc. LLZ Class II 1997-10-27
K971367 BRAINSCAN CONFORMAL RT MODULE Brainlab AG IYE Class II 1997-10-27
K972804 BANG POLYMER GEL DOSIMETER, BANG 533 Mgs Research, Inc. IYE Class II 1997-10-23
K971980 MCD-AC Adac Laboratories KPS Class II 1997-10-23
K973368 STRAIT'MAP OPTION Ge Medical Systems, Inc. IZI Class II 1997-10-17
K973039 LEGACY/LEGACY-D TABLE GE Medical Systems IXR Class II 1997-10-16
K972229 IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM Heartware, Inc. IZI Class II 1997-10-16
K973067 DRTS REMOTE CONTROL DRAPE Minrad, Inc. JAA Class II 1997-10-16
K972709 TBI STAND Mick Radio-Nuclear Instruments, Inc. IYE Class II 1997-10-16
K972973 PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM Perception, Inc. IYO Class II 1997-10-15
K972826 ESTEEM 1.5T MRI SYSTEM Elscint Mr, Inc. LNH Class II 1997-10-15
K972879 ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION Imatron, Inc. JAK Class II 1997-10-15
K972686 VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER Smv America KPS Class II 1997-10-14
K972130 DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR Fairmontmedical IZJ Class II 1997-10-09
K973342 DAR-3000B Shimadzu Corp. IZI Class II 1997-10-08
K973125 MAMMOLOADER BY C.M.A. SRL C.M.A. IXW Class II 1997-10-08
K973327 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH Shimadzu Medical Systems JAK Class II 1997-10-08
K973073 DRTS IMAGE INTENSIFIER DRAPE Minrad, Inc. JAA Class II 1997-10-08
K973329 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX Shimadzu Medical Systems JAK Class II 1997-10-08
K972204 ACU-RAY HF SERIES PORTABLE X-RAY UNIT Sterne Equipment Co., Ltd. IZL Class II 1997-10-08
K973219 AMBER DU Oldelft Corp. of America KPR Class II 1997-10-08
K963913 MD100 & MM150 Konica Medical Corp. EAM Class I 1997-10-08
K963914 CM & CM DS-7 Konica Medical Corp. IXA Class II 1997-10-08
K972847 KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) Eastman Kodak Company LMC Class II 1997-10-07
K965226 EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE Lunar Corp. KPS Class II 1997-10-03
K964617 GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems IYO Class II 1997-10-03
K972886 MIRAGE Segami Corp., Inc. LLZ Class II 1997-10-01
K972617 HELAX-VISIR Helax AB IYE Class II 1997-10-01
K973362 NEEDLE GUIDE/GRID Protek Medical Products, Inc. ITX Class II 1997-10-01
K971760 COLORPOINT OR PROFESSIONAL COLORPOINT Seiko Instruments USA, Inc. LMC Class II 1997-10-01
K972520 OPTIVIEW Optimed Technologies, Inc. LLZ Class II 1997-09-29
K972704 KINEMATIC POSITIONERS Ge Medical Systems, Inc. LNH Class II 1997-09-29
K972360 MULTISPECT 2 511 KEV COLLIMATOR Siemens Medical Solutions USA, Inc. KPS Class II 1997-09-23
K972399 ADVANTAGE WINDOWS VOLUME RENDERING OPTION Ge Medical Systems, Inc. JAK Class II 1997-09-23
K972366 IMNET DICOM NETWORK AGENT Imnet Systems, Inc. LMD Class I 1997-09-23
K972592 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) Elscint, Inc. MOS Class II 1997-09-15
K972296 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM Ge Medical Systems, Inc. MOS Class II 1997-09-15
K972256 FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS) Fujifilm Medical System U.S.A., Inc. LLZ Class II 1997-09-12
K972442 CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 Continental X-Ray Corp. JAA Class II 1997-09-11
K972380 KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) Eastman Kodak Company LMB Class I 1997-09-11
K972211 MULTIDOS, QC6PLUS Ptw-New York Corp. LHN Class II 1997-09-10
K972212 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER Ptw-New York Corp. LHN Class II 1997-09-10
K972191 DIGITIZER DIRECTOR (HSC025-01) Howtek, Inc. LMD Class I 1997-09-08
K972509 CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER Nuccardiac Software, Inc. KPS Class II 1997-09-08
K972275 LANTIS TREATSTATION Siemens Medical Solutions USA, Inc. IYE Class II 1997-09-08
K960527 LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM GE Medical Systems IYN Class II 1997-09-08
K972163 IMATION SE-196 LASER IMAGER Imation Corp. LMC Class II 1997-09-05
K972205 ALPHA 7000 QUADRATURE WRIST COIL Usa Instruments, Inc. MOS Class II 1997-09-05
K970464 P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 Northwest Medical Physics Equipment, Inc. IYE Class II 1997-09-05
K970627 E. CAM COINCIDENCE MODE (CM) Siemens Medical Solutions USA, Inc. KPS Class II 1997-09-04
K971717 FLY THROUGH Siemens Medical Solutions USA, Inc. JAK Class II 1997-09-03
K971176 VIEW ARCHIVING STATION Electromed Intl., Ltd. IZI Class II 1997-09-03
K972103 PHILIPS EASYVISION Philips Medical Systems North America, Inc. LLZ Class II 1997-09-02
K973115 ARRIPRO 35 ST/TV Arnold & Richter Cine Technik IXC Class I 1997-09-02
K971397 VIEWCATH 3-D CATHETER PULLBACK Quinton, Inc. ITX Class II 1997-08-25
K970990 GYREX PRIMA 1TG 1.0T MRI SYSTEM Elscint Mr, Inc. LNH Class II 1997-08-25
K971973 KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER Eastman Kodak Company LLZ Class II 1997-08-25
K964562 DTX-200 BONE DENSITOMETER Osteometer Meditech A/S KGI Class II 1997-08-22
K972966 AXT 150M MANUAL COLLIMATOR (AXT 150M) Applied X-Ray Technologies, Inc. IZX Class II 1997-08-21
K972340 INSIGHT 7000 PHASED ARRAY TORSO COIL Usa Instruments, Inc. MOS Class II 1997-08-21
K971894 KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM Eastman Kodak Company LMA Class II 1997-08-20
K971884 ASSET APOLLO Philips Medical Systems (Cleveland), Inc. LNH Class II 1997-08-20
K971848 TDK MEDICAL GRADE CD-R Tdk Electronics Corporation of America LMB Class I 1997-08-15
K971839 VARIAN RADIATION THERAPY IMAGING SYSTEM Varian Medical Systems, Inc. KPQ Class II 1997-08-15
K972152 DEVMED STEPPING AND STABILIZING SYSTEM Devmed Corp. ITX Class II 1997-08-15
K972465 ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 1997-08-15
K972766 PIVOTING COMPENSATING FILTERS FOR THE HEAD Octostop, Inc. KPR Class II 1997-08-14
K971878 VANTAGE 2.1 EXSPECT Adac Laboratories KPS Class II 1997-08-08
K972053 PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM Lunar Corp. KGI Class II 1997-08-08
K963290 COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM Endosonics Corp. IYO Class II 1997-08-06
K963451 ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING Topslane IYE Class II 1997-08-05
K971684 MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) Siemens Medical Solutions USA, Inc. LNH Class II 1997-08-05
K970508 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems IYO Class II 1997-08-04
K955668 INTRACAVITY NEEDLE GUIDE KIT Arlanda Medicinska Instrument Co. AB ITX Class II 1997-07-30
K970384 VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 Aktina Medical Physics Corp. IYE Class II 1997-07-29
K964886 GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems IYN Class II 1997-07-29
K972672 BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY Barzell-Whitmore Maroon Bells, Inc. ITX Class II 1997-07-29
K971181 THE MIDVIEW-MEDCON'S DICOM VIEWER Medcon , Ltd. IZI Class II 1997-07-29
K971668 SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS GE Medical Systems LNH Class II 1997-07-24
K972348 HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM Hewlett-Packard Co. ITX Class II 1997-07-24
K965010 TARGET 2 VERSION 1.1 GE Medical Systems IYE Class II 1997-07-23
K971667 CARDIAC PHASED ARRAY COIL GE Medical Systems MOS Class II 1997-07-23
K971942 SLED, FINGER, HANDLE Biosound Esaote, Inc. ITX Class II 1997-07-23
K962950 CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. IYE Class II 1997-07-22
K970573 FLEXART V3.5 SOFTWARE Toshiba America Mri, Inc. LNH Class II 1997-07-21
K964952 VERIDOSE V (FIVE), MODEL NUMBER 37-705 Victoreen, Inc. JAD Class II 1997-07-21
K965068 MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE Toshiba America Medical Systems, In.C LNH Class II 1997-07-15
K963789 DTX-100 BONE DENSITOMETER Osteometer Meditech A/S KGI Class II 1997-07-14
K971776 ECHOVACS Vmi Technologies LLZ Class II 1997-07-14
K970819 TARGOBEAM Ferguson Medical JAK Class II 1997-07-14
K971722 TRANS VAGINAL NEEDLE GUIDE Protek Medical Products, Inc. ITX Class II 1997-07-10
K970236 THERAPLAN PLUS VERSION 1.2 Theratronics, Inc. IYE Class II 1997-07-09
K971700 BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER Biosound, Inc. ITX Class II 1997-07-09
K972000 X-RAY ASSIST BAR Ralph Lindel, D.C. KPR Class II 1997-07-08
K971489 RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 Philips Medical Systems North America, Inc. IZI Class II 1997-07-03

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