meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
31
Latest Decision
1996-07-31

Clearances · page 108 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K961689 INFINET Infimed, Inc. LMD Class I 1996-07-31
K951976 ECHO. AKHO Alliance Medical, Inc. IYO Class II 1996-07-26
K955844 APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER Varian Assoc., Inc. JAQ Class II 1996-07-26
K961007 EXPERT SPINE MORPHOTIETRY REFERENCE Lunar Corp. KGI Class II 1996-07-25
K961876 AIRIS Hitachi Medical Systems America, Inc. LNH Class II 1996-07-25
K961029 KILTEX PROBE COVER Kiltex Corp. IYO Class II 1996-07-25
K962140 ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300 Continental X-Ray Corp. JAA Class II 1996-07-25
K961753 SHARED VISION(PART NUMBER SV 0015) Imagelabs, Inc. LMD Class I 1996-07-25
K961453 KODAK MN-R 2000 CASSETTE Eastman Kodak Company IXA Class II 1996-07-25
K961757 ECOGEL 100 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc. ITX Class II 1996-07-25
K960083 MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 Wuestec Medical, Inc. IXQ Class II 1996-07-24
K955414 XRT 400 Wuestec Medical, Inc. KXJ Class II 1996-07-24
K961577 PRISM 3000XPV SYSTEM (210714) Philips Medical Systems (Cleveland), Inc. KPS Class II 1996-07-23
K962308 EUB-905 Hitachi Medical Corp. of America IYO Class II 1996-07-17
K961391 FLEXART QD HEAD/NECK COIL Toshiba America Mri, Inc. MOS Class II 1996-07-09
K960497 FLEXIBLE PHASED ARRAY SPINE COIL Philips Medical Systems (Cleveland), Inc. LNH Class II 1996-07-05
K961011 DTX-200 BONE DENSITOMETER Shotwell & Carr, Inc. KGI Class II 1996-07-05
K961464 SELECT/SP Elscint, Inc. JAK Class II 1996-07-03
K961637 PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL) Philips Medical Systems (Cleveland), Inc. LLZ Class II 1996-07-03
K962336 RADIOGRAPHIC FILM CASSETTES Unidex Group, Inc. IXA Class II 1996-07-03
K961377 MANAN PROSTATE LOCKING INTRODUCER SET Manan Medical Products, Inc. IWJ Class I 1996-07-03
K961451 DICOMNET Lockheed Martin Communications Systems IZI Class II 1996-07-03
K961366 MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS Mri Devices Corp. LNH Class II 1996-07-03
K960265 ADVANTAGE WINDOWS WITH FUNCTOOL OPTION GE Medical Systems LLZ Class II 1996-07-03
K961944 LUNAR REPORT GENERATOR Lunar Corp. KGI Class II 1996-07-03
K961403 LIFE IMAGING SYSTEMS LIS 6000 A Life Imaging Systems, Inc. LLZ Class II 1996-07-03
K961680 SONY DKR-700 DIGITAL STILL RECORDER Sony Medical Systems LMB Class I 1996-07-03
K962338 RADIOGRAPHIC GRID Unidex Group, Inc. IXJ Class I 1996-07-03
K961307 SMART SPOT Cmt Medical Technologies, Ltd. LLZ Class II 1996-07-01
K961238 MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1 Toshiba America Mri, Inc. LNH Class II 1996-06-28
K961690 CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 Continental X-Ray Corp. JAA Class II 1996-06-27
K953911 PHILIPS EASYVISION Philips Medical Systems, Inc. LLZ Class II 1996-06-27
K961174 ECG MONITOR MODEL DS-3130/3140 Hitachi Medical Systems America, Inc. LNH Class II 1996-06-21
K961170 BREAST TREATMENT AID S. and H. Engineering, Inc. IYE Class II 1996-06-19
K961121 KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 1996-06-19
K955457 DIGISCAN 2 PLUS Siemens Medical Solutions USA, Inc. LLZ Class II 1996-06-18
K961055 CT PROSPEED CT/I GE Medical Systems JAK Class II 1996-06-17
K961208 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER Ptw-New York Corp. IYE Class II 1996-06-17
K961193 FULL FRAME ZOOM SYSTEM Xre Corp. JAA Class II 1996-06-17
K961092 VISART Toshiba America Medical Systems, In.C LNH Class II 1996-06-14
K935024 ESI-5000 Elscint, Inc. IYN Class II 1996-06-12
K961160 UPACS VERSION 1.7 Base Ten Systems, Inc. LMB Class I 1996-06-11
K955389 MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 1996-06-10
K960981 KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY Kodak Health Imaging Systems, Inc. LMB Class I 1996-06-07
K960892 THE COBALT SCALPEL Nova Therapeutic System IWB Class II 1996-06-03
K960941 UPACS Base Ten Systems, Inc. LMB Class I 1996-06-03
K955687 RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY Contour Fabricators of Florida, Inc. JAA Class II 1996-06-03
K960901 MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL Medrad, Inc. LNH Class II 1996-05-29
K960911 NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE Scimage, Inc. LMD Class I 1996-05-29
K960973 MOVABLE ADD-ON COUCH FOR OUTLOOK Philips Medical Systems (Cleveland), Inc. LNH Class II 1996-05-29
K960834 KODAK EC-L CASSETTE Eastman Kodak Company IYE Class II 1996-05-28
K954884 PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 Vingmed Sound, Inc. IYO Class II 1996-05-28
K946349 STENODOC Specs USA, Inc. IYO Class II 1996-05-24
K955840 BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 Diagnostic Ultrasound Corp. IYO Class II 1996-05-24
K955236 GREEN TEC-2100 Medtec, Inc. IWE Class I 1996-05-24
K960737 MODEL 555 010 XY CONVERSION(55010) Systems Supply Services, Inc. KPQ Class II 1996-05-22
K951449 MODEL KM-25 Koven Technology, Inc. IYO Class II 1996-05-20
K960920 CLINIX MP Philips Medical Systems (Cleveland), Inc. OWB Class II 1996-05-20
K960907 ORCA Lunar Corp. OXO Class II 1996-05-20
K941593 DIAGNOSTIC ULTRASONIC TRANSDUCER Toshiba America Medical Systems, In.C IYO Class II 1996-05-17
K955583 VIFS Konica Medical Corp. JAK Class II 1996-05-14
K960622 I-SCAN Ophthalmic Technologies, Inc. IYO Class II 1996-05-13
K955092 ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE SERVER, PRINT SPOOLER, ANALOG & DIGITAL ACQUIRE Cemax-Icon, Inc. LLZ Class II 1996-05-09
K955519 ANALYTICAL REVIEW STATION Camtronics, Ltd. IZI Class II 1996-05-09
K960946 ECHONET Lockheed Martin Communications Systems LLZ Class II 1996-05-07
K960575 ADVANTX LCV+ GE Medical Systems IZI Class II 1996-05-07
K953165 ULTRA COMPACT VIDEO IMAGER International Imaging Electronics LMC Class II 1996-05-07
K960665 ECHO-COM FOR MS-WINDOWS VERSION 2.0 Cone Instruments, Inc. LLZ Class II 1996-05-07
K950330 DIGITAL IMAGE ACQUISITION SYSTEM International Imaging Electronics IYO Class II 1996-05-07
K961022 TANGENT VI TABLE Fischer Imaging Corp. IXR Class II 1996-05-03
K960613 GE ADVANTAGE WINDOWS REVIEW WORKSTATION GE Medical Systems LLZ Class II 1996-04-30
K960381 MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION Elscint, Inc. IZH Class II 1996-04-29
K960338 STEREOTACTIC BODY FRAME Elekta Instrument AB IYE Class II 1996-04-23
K954564 PID-1 PRECISION INTELLIGENT DOSIMETER Gammex, Inc. IYE Class II 1996-04-22
K960510 THERAVIEW Infimed, Inc. IYE Class II 1996-04-22
K960294 PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK Philips Medical Systems (Cleveland), Inc. LNH Class II 1996-04-19
K960382 KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER Eastman Kodak Company LMD Class I 1996-04-17
K953716 INTRACAVITY TRANSDUCERS Biosound, Inc. ITX Class II 1996-04-17
K960071 IMAGEFUSION Radionics Software Applications, Inc. LLZ Class II 1996-04-17
K950972 REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A Toshiba America Medical Systems, In.C JAK Class II 1996-04-15
K945957 AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER Kleinfeld, Kaplan and Becker IYN Class II 1996-04-15
K951994 OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER Olympus America, Inc. IYO Class II 1996-04-15
K954354 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY General Electric Co. LNH Class II 1996-04-12
K955251 OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM Imaging Services, Inc. OXO Class II 1996-04-12
K954567 RTI MEDICAL Radiology Telenetwork Intl. LMD Class I 1996-04-12
K943338 BIOSENSOR BIDOP VASCULAR TEST SYSTEM Biosensor Corp. JAF Class II 1996-04-12
K954353 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY General Electric Co. LNH Class II 1996-04-12
K940663 PEACOCK PLAN Nomos Corp. IYE Class II 1996-04-09
K953530 DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A Biosound, Inc. IYO Class II 1996-04-08
K955327 HP SONOS 100CF ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. IYN Class II 1996-04-08
K951942 LAST IMAGE HOLD Insight Systems LMB Class I 1996-04-08
K960330 INSTATRAK Visualization Technology, Inc. LLZ Class II 1996-04-08
K951581 PINNACLE3 APEX Adac Laboratories IYE Class II 1996-04-08
K960809 PHILIPS SITE VIEW WORKSTATION Philips Medical Systems North America, Inc. LMD Class I 1996-04-07
K950157 SIEMENS Q64XXX Siemens Medical Solutions USA, Inc. IYO Class II 1996-04-05
K955825 SMITH S-100 TIME & TEMPERATURE CONTROL Smith Companies Dental Products EGY Class II 1996-04-05
K955237 TIGERSCAN/TIGERVIEW Tau Corp. LMB Class I 1996-04-04
K960635 PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS Siemens Medical Solutions USA, Inc. JAK Class II 1996-04-03
K960998 XRE COLLIMATOR Xre Corp. IZW Class II 1996-04-03
K953113 SBDX MOBILE FLUOROSCOPY SYSTEM Cardiac Mariners, Inc. JAA Class II 1996-03-29

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