meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
1998-06-17

Clearances · page 102 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K980234 THE NETWORK SYSTEM Medical Sni , Ltd. LLZ Class II 1998-06-17
K973864 COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO Pausch Corp. IZF Class II 1998-06-17
K981056 VARIAN XIMATRON SCAN VISION CT Varian Medical Systems, Inc. KPR Class II 1998-06-12
K980569 FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS Norland Corp. KGI Class II 1998-06-12
K980289 FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER Norland Corp. KGI Class II 1998-06-12
K981027 E.CAM LSO 311 PET/SPECT SYSTEM Cti Pet Systems, Inc. KPS Class II 1998-06-08
K980970 IIRAD DIRECTRAY OPERATOR CONSOLE Sterling Diagnostic Imaging, Inc. LLZ Class II 1998-06-08
K974880 PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM Perception, Inc. IYO Class II 1998-06-08
K980904 MUCHECK MONITOR UNIT VALIDATION PROGRAM Medical Dosimetry Services, Inc. IYE Class II 1998-06-08
K980867 3D-MSPECT Adac Laboratories KPS Class II 1998-06-04
K980959 VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA Ge Medical Systems F.I. Haifa KPS Class II 1998-06-04
K981124 ACCUDEXA BONE DENSITOMETER Schick Technologies, Inc. KGI Class II 1998-06-04
K980914 EMORY CARDIAC TOOL BOX Emory University KPS Class II 1998-06-04
K980918 JPACS Philips Medical Systems (Cleveland), Inc. LMD Class I 1998-06-03
K974344 CT SCOPE Elscint, Inc. JAK Class II 1998-06-03
K981398 ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM Interneuron Pharmaceuticals, Inc. LNH Class II 1998-06-01
K973936 FOCUS RTP SYSTEM Computerized Medical Systems, Inc. IYE Class II 1998-06-01
K980826 EQUIDOSE SOLID STATE DIODE DETECTORS Cii Mastek, Inc. IYE Class II 1998-06-01
K981626 SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYO Class II 1998-05-27
K974882 DOWNSCAN LT Merlin Engineering Works, Inc. LMD Class I 1998-05-22
K980687 SONOS 5500 ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. IYO Class II 1998-05-22
K974513 PINPOINT Philips Medical Systems (Cleveland), Inc. JAK Class II 1998-05-20
K980837 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS Shimadzu Medical Systems JAK Class II 1998-05-20
K980125 REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER Norland Corp. KGI Class II 1998-05-20
K981404 FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 Fukuda Denshi USA, Inc. IYO Class II 1998-05-20
K980750 RADIOCAMERAS PATIENT POSITIONING SYSTEM Surgical Navigation Technologies, Inc. IYE Class II 1998-05-20
K980379 PROWESS PRO-SIM Ssgi Prowess Systems IYE Class II 1998-05-18
K980809 LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER Lumisys, Inc. LMA Class II 1998-05-11
K980691 AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc. MOS Class II 1998-05-11
K980645 PHILIPS GYROSCAN NT RELEASE 6 SERIES Philips Medical Systems North America, Inc. LNH Class II 1998-05-11
K981510 SONOACE 6000/ ULTRAMARK 400 Medison America, Inc. IYO Class II 1998-05-08
K981505 COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM Sonosite,Inc. IYO Class II 1998-05-08
K980308 ECHOTECH 3D FREESCAN Echotech 3D Imaging Systems GmbH IYO Class II 1998-05-06
K980629 VSS, VIRTUAL SIMULATION SYSTEM Nucletron Corp. IYE Class II 1998-05-06
K981267 FACTS MONOBLOCK Dynarad Corp. IZX Class II 1998-05-06
K980715 AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS) Adac Laboratories KPS Class II 1998-05-06
K980684 VR NETSERVE I.S.G. Technologies, Inc. LMD Class I 1998-05-06
K973658 DIFFUSION PACKAGE / GYROSCAN NT Philips Medical Systems North America, Inc. LNH Class II 1998-05-06
K980417 MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V Medrad, Inc. LNH Class II 1998-05-04
K973834 CS2000 & CS2000 TOMO Pausch Corp. IZF Class II 1998-04-30
K974438 MEDRAD ATD-T INTERFACE DEVICE Medrad, Inc. MOS Class II 1998-04-30
K981280 CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS Bayer Corp., Agfa Div. IXW Class II 1998-04-30
K980322 ACCENT 16, ACCENT 22 GE Medical Systems OXO Class II 1998-04-24
K980557 SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING Siemens Medical Solutions USA, Inc. IYN Class II 1998-04-24
K980402 CAPINTEC MODEL 292 ELECTROMETER Capintec, Inc. IYE Class II 1998-04-24
K973556 IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 Imex Medical Systems, Inc. IYN Class II 1998-04-24
K980851 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 Boston Scientific Corp IYO Class II 1998-04-22
K964001 SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM Med Institute, Inc. ITX Class II 1998-04-17
K980296 OLDELFT DIGIDELCA Oldelft Corp. of America KPR Class II 1998-04-17
K974315 VIDAR VXR LS LASER FILM DIGITIZER Vidar Systems Corp. LMA Class II 1998-04-17
K973562 IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 Imex Medical Systems, Inc. IYN Class II 1998-04-15
K980169 HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS General Electric Co. JAK Class II 1998-04-13
K980176 HISPEED QX/I CT SCANNER SYSTEM General Electric Co. JAK Class II 1998-04-13
K980157 PREMIER 7000 CTL SPINE COIL Usa Instruments, Inc. MOS Class II 1998-04-13
K980541 BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY Barco NV Display Systems LMD Class I 1998-04-09
K980091 LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 Cosmaceutical Marketing, Inc. ITX Class II 1998-04-09
K980235 REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) Kci New Technologies, Inc. IZH Class II 1998-04-09
K980243 PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) Parameter Developments, Inc. LMB Class I 1998-04-03
K980860 HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM Atlantis Diagnostics Intl., Inc. IYO Class II 1998-04-02
K980168 COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE Analogic Corp. LLZ Class II 1998-04-02
K980306 GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP Elscint, Inc. LNH Class II 1998-04-02
K973441 LEKSELL GAMMAPLAN Patterson Consulting Group, Inc. IWB Class II 1998-04-01
K980114 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems LNH Class II 1998-03-30
K974679 THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM Medcon , Ltd. IZI Class II 1998-03-23
K980722 TRIMAX RADIOGRAPHIC CASSETTE Imation Corp. IXA Class II 1998-03-23
K980565 LD2000 SERIES General Scanning, Inc. LMA Class II 1998-03-19
K974544 ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER Aloka Co., Ltd. ITX Class II 1998-03-18
K980213 DI-2000 Lumisys, Inc. LMA Class II 1998-03-17
K974863 IMIX DIGITAL THORAX SYSTEM Advanced Instrument Development, Inc. KPR Class II 1998-03-17
K980118 KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER Eastman Kodak Company LLZ Class II 1998-03-17
K980241 NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE Netco Communications Corp. LMD Class I 1998-03-17
K974703 CARBON FIBER BREAST BOARD Medtec, Inc. IYE Class II 1998-03-10
K974844 OUTLOOK SYSTEM ENHANCEMENT PACKAGE Philips Medical Systems (Cleveland), Inc. LNH Class II 1998-03-10
K974597 ADC COMPACT (AGFA DIAGNOSTIC CENTER) Bayer Corp., Agfa Div. KPR Class II 1998-03-09
K974614 GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 Elscint, Inc. LNH Class II 1998-03-04
K974700 MATRIX MT-MX3 Medtec, Inc. IYE Class II 1998-03-04
K974755 DYNA VUE 3-D IMAGING PRODUCT Imd Systems, Inc. LLZ Class II 1998-03-04
K973802 SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM Shimadzu Medical Systems IYO Class II 1998-03-04
K974504 EPS E For M Imaging Systems Div., Marquette Electronic LLZ Class II 1998-02-27
K974498 STRATIS II Hitachi Medical Systems America, Inc. LNH Class II 1998-02-26
K974619 SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM Afp Imaging Corp. LMA Class II 1998-02-25
K974256 ECAT PET SCANNERS Cti Pet Systems, Inc. KPS Class II 1998-02-25
K980060 ECHOLINK Mpacs, LLC LLZ Class II 1998-02-25
K974522 3D I-SCAN Ophthalmic Technologies, Inc. IYO Class II 1998-02-25
K974474 PEGASYS INTOUCH Adac Laboratories LLZ Class II 1998-02-24
K974455 ANATOM 1000 (A MINUS, A-) Analogic Corp. JAK Class II 1998-02-20
K972554 REGANES RADIONUCLIDE SEED MAGAZINE Avid N.I.T., Inc. IWJ Class I 1998-02-17
K974355 INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) Ge Dec Medical Systems OWB Class II 1998-02-17
K980220 IISYS PACS SYSTEM Sterling Diagnostic Imaging, Inc. LMD Class I 1998-02-13
K974437 EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE Lunar Corp. KGI Class II 1998-02-13
K974367 ADVANTX LCN, ADVANTX LCLP GE Medical Systems IZI Class II 1998-02-13
K974444 NUMASTATION Numa, Inc. KPS Class II 1998-02-13
K974307 RTR-2000/RTR-4000 Terarecon,Inc. JAK Class II 1998-02-13
K973459 NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS Norland Corp. KGI Class II 1998-02-13
K972771 PHASED ARRAY TRANSDUCER - - PVF -375DT Toshiba America Medical Systems, In.C ITX Class II 1998-02-11
K974239 AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM Aktina Medical Physics Corp. IXI Class II 1998-02-10
K974212 AIRIS II Hitachi Medical Systems America, Inc. LNH Class II 1998-02-09
K974432 ULTRAGUIDE 1000 Ultraguide , Ltd. IYO Class II 1998-02-09
K974301 CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER Clk Intl., Inc. ITX Class II 1998-02-06
K974530 DUFFUSION-WEIGHTED MR IMAGING PACKAGE Philips Medical Systems (Cleveland), Inc. LNH Class II 1998-02-06

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