meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
33
Latest Decision
1998-02-06

Clearances · page 103 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K974310 NOMOS SLIT COLLIMATOR (BEAK) Nomos Corp. IYE Class II 1998-02-06
K973336 IMEX STETHODOP Imex Medical Systems, Inc. JAF Class II 1998-02-05
K972990 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE Medical Systems LNH Class II 1998-02-05
K971965 PHILIPS EASYVISION Philips Medical Systems, Inc. LLZ Class II 1998-01-30
K974130 VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE Dejarnette Research Systems LMD Class I 1998-01-29
K973104 NORLAND MODEL PDEXA BONE DENSITOMETER Norland Corp. KGI Class II 1998-01-29
K974112 VACUDAP, MODEL 2000, 2001 Victoreen, Inc. KPR Class II 1998-01-29
K974134 X-SIGHT DIGITAL IMAGING SYSTEM Stallion Technologies, Inc. LLZ Class II 1998-01-27
K974255 CD-R STATION AND VRS-2000 Electromed Intl., Ltd. LMD Class I 1998-01-27
K974308 MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY Medrad, Inc. MOS Class II 1998-01-27
K973037 N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 Avid N.I.T., Inc. IWJ Class I 1998-01-27
K972816 ADVANCED TREATMENT PLANNING SYSTEM Advanced Radiation Therapy Systems, Inc. IYE Class II 1998-01-23
K974118 WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET Worldwide Medical Technologies, LLC IWJ Class I 1998-01-23
K973713 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR Cardiovascular Dynamics, Inc. ITX Class II 1998-01-23
K973848 IBU, INTEGRATED BRACHY THERAPY UNIT Nucletron Corp. KPQ Class II 1998-01-22
K974207 PHILIPS EASYVISION WORKSTATION Philips Medical Systems North America, Inc. LLZ Class II 1998-01-22
K973958 GENERAL PURPOSE ATL NEEDLE GUIDE KIT Protek Medical Products, Inc. ITX Class II 1998-01-22
K972451 COREGISTRATION FUNCTION Nomos Corp. IYE Class II 1998-01-22
K973396 QUEST PET IMAGING SYSTEM Ugm Medical Systems, Inc. KPS Class II 1998-01-21
K974107 KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) Eastman Kodak Company LMD Class I 1998-01-21
K974086 KODAK DIGITAL SCIENCE CARDIAC VIEWER Eastman Kodak Company LLZ Class II 1998-01-20
K974102 MILTRA IMAGING INC., IMAGE VAULT Mitra Imaging, Inc. LMD Class I 1998-01-20
K973960 MODEL 37-185 Victoreen, Inc. LHN Class II 1998-01-14
K973963 120 LEAF MULTILEAF COLLIMATOR Mitsubishi Electronics America, Inc. IYE Class II 1998-01-14
K973953 AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM Aktina Medical Physics Corp. IXI Class II 1998-01-14
K974058 FS IV MINI C-ARM SYSTEM Hologic, Inc. JAA Class II 1998-01-12
K971116 SONOS 5500 IMAGING SYSTEM Hewlett-Packard Co. ITX Class II 1998-01-12
K973983 PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D Philips Medical Systems, Inc. LLZ Class II 1998-01-08
K973835 PHILIPS EASYVISION WORKSTATION Philips Medical Systems, Inc. LLZ Class II 1998-01-06
K972701 BARCO MWD 321 MEDICAL WORKSTATION DISPLAY Barco NV Display Systems LMD Class I 1998-01-02
K973799 CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT Siemens Medical Solutions USA, Inc. LNH Class II 1998-01-02
K973786 NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE Nw Radiation Therapy Products IWJ Class I 1998-01-02
K973805 IMAGEACCESS SYSTEM Storcomm, Inc. LMD Class I 1998-01-02
K973787 MEDRAD 1.5T EXTREMITY ARRAY Medrad, Inc. MOS Class II 1997-12-30
K955893 EVERYTIME TRANSFUCER COVER Amedic AB ITX Class II 1997-12-30
K973833 CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL Dynarad Corp. IZL Class II 1997-12-30
K973744 UNICATH SP BI-PLANE (MODEL M269 & M289) Xre Corp. JAA Class II 1997-12-29
K973857 FLOSTAT VASCULAR REPORT GENERATOR (VRG) Biomedix, Inc. JAF Class II 1997-12-29
K973631 LORAD M-III ELITE (M-III E) Lorad Corp. IZH Class II 1997-12-23
K973644 FLOSTAT VASCULAR LAB Biomedix, Inc. JAF Class II 1997-12-23
K973767 HARMONIC IMAGING WITH CONTRAST Acuson Corp. IYO Class II 1997-12-23
K973638 N.I.T., INC. NEEDLE GUIDING TEMPLATE Avid N.I.T., Inc. IWJ Class I 1997-12-23
K974240 LIGHTLINE-M Wuestec Medical, Inc. IZX Class II 1997-12-22
K973908 AUKLET CT SCANNER, TSX-003A Toshiba America Medical Systems, In.C JAK Class II 1997-12-22
K970901 GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM GE Medical Systems IYO Class II 1997-12-22
K973959 OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE Olicon Imaging Systems, Inc. LMD Class I 1997-12-22
K974423 ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL Sterling Diagnostic Imaging, Inc. EAM Class I 1997-12-22
K973710 DIGITAL ADD ON MULTI SYSTEM Swissray International, Inc. KPR Class II 1997-12-18
K972192 PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM Perception, Inc. IYO Class II 1997-12-17
K973540 ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS Elekta Oncology Systems, Inc. IYE Class II 1997-12-17
K971790 KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) Urometrics, Inc. IYN Class II 1997-12-17
K973793 OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE Olicon Imaging Systems, Inc. LMD Class I 1997-12-17
K972365 COMPACT OR COMP-X Eurotec, S.R.L. IZL Class II 1997-12-12
K971528 ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) Fujinon, Inc. IYO Class II 1997-12-12
K973965 SMART MOTORIZED VIEWER Smartlight, Ltd. IXC Class I 1997-12-12
K973653 SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM Areeda Assoc., Ltd. LLZ Class II 1997-12-12
K973712 MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT Minxray, Inc. IZL Class II 1997-12-12
K973842 CARBON FIBER CONFORMAL COUCH TOP Medtec, Inc. IXQ Class II 1997-12-05
K972925 ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC Access Radiology Corp. LMD Class I 1997-12-05
K973630 CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM Siemens Medical Solutions USA, Inc. MOS Class II 1997-12-05
K973421 IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} Dejarnette Research Systems LMD Class I 1997-12-05
K973411 DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) General Scanning, Inc. LMA Class II 1997-12-04
K973206 STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY Sterling Diagnostic Imaging, Inc. MQB Class II 1997-12-04
K972016 AUTIMO 2.5-D AND AUTIMO 3-D C.L. Mcintosh & Assoc., Inc. IXI Class II 1997-12-04
K971735 ACCUDEXA BONE DENSITOMETER Schick Technologies, Inc. KGI Class II 1997-12-02
K973315 THERAPAX DXT 300 MODEL HF-300 Pantak, Inc. JAD Class II 1997-12-02
K973463 OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE O Tech, Inc. LMB Class I 1997-12-02
K973239 DICOM 3.0 SOFTWARE VERSION 2.0 Adac Laboratories LMD Class I 1997-11-26
K973622 TRANSDUCER POSITIONER Protek Medical Products, Inc. ITX Class II 1997-11-26
K973413 ID. STORE (RELEASE 2.0) I.S.G. Technologies, Inc. LMB Class I 1997-11-25
K973233 IMAGE FUSION AND REVIEW SYSTEM Adac Laboratories KPS Class II 1997-11-25
K973303 IMATION MODEL 9410 NETWORK INTERFACE Imation Corp. LMD Class I 1997-11-25
K973270 LEG'MAP OPTION Ge Medical Systems, Inc. IZI Class II 1997-11-25
K973168 SMARTVIEW OPTIONS FOR HISPEED CT/I GE Medical Systems JAK Class II 1997-11-21
K970136 DIGITAL ADD-ON BUCKY Swissray Teleray AG KPR Class II 1997-11-21
K973889 VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE Varian Medical Systems, Inc. IYE Class II 1997-11-21
K973856 GIOTTO HT Sitco, Inc. IZH Class II 1997-11-21
K973184 PROSTATE SEEDING NEEDLE Promex, Inc. IWJ Class I 1997-11-21
K973148 MACOM A.Stein - Regulatory Affairs Consulting LLZ Class II 1997-11-20
K973162 DUAL RADIATION TARGETING SYSTEM DRTS DRAPE Hogan & Hartson IWE Class I 1997-11-20
K972215 MEDIMAGE Vepro - Computersysteme GmbH LLZ Class II 1997-11-19
K972822 IMATION SE-204 LASER IMAGER Imation Enterprises Corp. LMC Class II 1997-11-19
K972517 EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE Lunar Corp. KGI Class II 1997-11-18
K973450 SENSOR PAD Inventive Products, Inc. IYO Class II 1997-11-14
K970782 IMAGING JET SYSTEM General Robotic Devices, Inc. JAB Class II 1997-11-13
K971893 SNT LINAC ACCESSORIES Surgical Navigation Technologies, Inc. IYE Class II 1997-11-13
K973065 REALVIEW TELEMEDICINE SYSTEM Vcom Systems, Inc. LLZ Class II 1997-11-13
K973131 SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) Siemens Medical Solutions USA, Inc. LMD Class I 1997-11-12
K973493 PLANMED CYTOGUIDE Planmed OY IZH Class II 1997-11-10
K973482 PHILIPS INTEGRIS V5000 AND BV5000 Philips Medical Systems North America, Inc. IZI Class II 1997-11-10
K973010 REALTIME 3D DIAGNOSTIC WORKSTATION Siemens Medical Solutions USA, Inc. LLZ Class II 1997-11-10
K973598 SIREMOBIL CO2 Siemens Medical Solutions USA, Inc. OXO Class II 1997-11-10
K973915 INFLATABLE POSITIONING CUSHIONS Kci New Technologies, Inc. IZH Class II 1997-11-10
K973400 MAMMOTEST ADAPTER DRIVER Fischer Imaging Corp. IZH Class II 1997-11-10
K972660 RAVEN DRY PRINTER Sterling Diagnostic Imaging, Inc. LMC Class II 1997-11-10
K973081 DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) Howtek, Inc. LLZ Class II 1997-11-05
K973079 L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM Acuson Corp. ITX Class II 1997-11-05
K972903 IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS Imatron, Inc. JAK Class II 1997-11-04
K972655 CONTROL SYRINGE Medical Specialties Intl., Inc. IZI Class II 1997-11-04
K972882 APOLLO Norland Corp. KGI Class II 1997-10-31

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