meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
26
Latest Decision
2010-08-04

Clearances · page 65 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K101391 SCANDIA-45 GAMMA CAMERA SYSTEM Scandia Corporation IYX Class I 2010-08-04
K101279 CORRIDOR4DM V2010 MODEL: V2010 Invia LLZ Class II 2010-08-04
K101503 DUSIMETRY CHECK Math Resolutions, LLC IYE Class II 2010-08-04
K101289 SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB Air Techniques, Inc. MQB Class II 2010-08-03
K101949 PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 Shanghai Chenguang Medical Technologies Co, Ltd. MOS Class II 2010-07-28
K101295 MROPEN Paramed S.R.L. LNH Class II 2010-07-28
K101076 PROWESS PANTHER PROARC, MODEL VERSION 5.0 Prowess, Inc. MUJ Class II 2010-07-27
K101662 SYNAPSE 3D BASIC TOOLS Fujifilm Medical System U.S.A., Inc. LLZ Class II 2010-07-26
K092328 MED-SEG, MODEL BTMS 1000 Bartron Medical Imaging, Inc. LLZ Class II 2010-07-26
K101833 INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 Infimed, Inc. OWB Class II 2010-07-23
K092830 DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 VATECH Co., Ltd. KPR Class II 2010-07-21
K100766 IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 Ion Beam Applications S.A. LHN Class II 2010-07-21
K101455 EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2010-07-19
K101829 THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. ITX Class II 2010-07-16
K092713 SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM Transamerican Medical Imaging IZL Class II 2010-07-16
K100762 FLAT PANEL DETECTOR, MODEL FDR D-EVO Fujifilm Medical Systems U.S.A, Inc. MQB Class II 2010-07-15
K101796 PACSMATE MMD-5201M MONITOR Iei Technology Corp. LLZ Class II 2010-07-15
K101858 PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 Shanghai Chenguang Medical Technologies Co, Ltd. MOS Class II 2010-07-14
K100890 VARIAN HIGH ENERGY LINEAR ACCELERATOR Varian Medical Systems IYE Class II 2010-07-13
K093967 VARIAN TREATMENT Varian Medical Systems, Inc. IYE Class II 2010-07-12
K101411 SAVI PREPARATION DEVICE Cianna Medical, Inc. JAQ Class II 2010-07-12
K101491 UROSKOP OMNIA Siemens Medical Solutions USA, Inc. JAA Class II 2010-06-30
K100931 MYLABTWICE, MODEL 6200 Esaote, S.p.A. IYN Class II 2010-06-25
K101091 Z.ONE ULTRA ULTRASOUND SYSTEM Zonare Medical Systems, Inc. IYN Class II 2010-06-25
K100001 MOBIVISION Almana Medical Imaging MQB Class II 2010-06-25
K100989 ZURA TEE SYSTEM WITH CLARITEE PROBE Imacor, Inc. IYN Class II 2010-06-25
K101228 MIRADA XD Mirada Medical, Ltd. LLZ Class II 2010-06-23
K101492 8 CHANNEL CARDIAC PHASED ARRAY COIL Ge Healthcare Coils (Usa Instruments, Inc.) MOS Class II 2010-06-23
K092915 CEDARA WEBACCESS, MODEL: 2.4 Cedara Software Corp. LLZ Class II 2010-06-23
K093197 CORONIS FUSION 10MP, MODEL MDCG-10130 Barco N.V. LLZ Class II 2010-06-23
K100801 PUMA MODEL VERSION 1.0 Prowess, Inc. IYE Class II 2010-06-18
K093810 BF-NAVI Kgt, Inc. JAK Class II 2010-06-18
K101131 FIDUCIAL MARKERS Cosman Medical, Inc. IYE Class II 2010-06-17
K093466 HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS Hitachi Medical Systems America, Inc. IYO Class II 2010-06-17
K093395 OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE Olympus Medical Systems Corporation IYN Class II 2010-06-17
K092564 O-ARM IMAGING SYSTEM Medtronic Navigation, Inc. (Littleton) OXO Class II 2010-06-17
K091928 10 X 10 VISION Bioptics, Inc. MWP Class II 2010-06-16
K101119 SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 Siemens Medical Solutions USA, Inc. MUJ Class II 2010-06-16
K101008 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY Shantou Institute of Ultrasonic Instruments (Siui ITX Class II 2010-06-08
K101013 MODIFICATION TO SCINTRON IV Miegmbh KPS Class II 2010-06-07
K100637 SYNGO.CT CORONARY ANALYSIS Siemens AG Medical Solutions JAK Class II 2010-05-26
K100849 SYNC-RX SYSTEM, MODEL AS00010 Sync-Rx, Ltd. IZI Class II 2010-05-21
K100363 ULTRA DCI MODEL 5000 Ultrasound Medical Devices, Inc. IYO Class II 2010-05-21
K100847 SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 Biocompatibles, Inc. KXK Class II 2010-05-21
K093738 MRI PATIENT POSITIONING DEVICES Medtec, Inc. LNH Class II 2010-05-14
K092164 TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA Shenzhen Delicate Electronics Co., Ltd. OQQ Class II 2010-05-13
K100691 OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 Bionix Development Corp. IYE Class II 2010-05-11
K100619 SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 Siemens Medical Solutions USA, Inc. LLZ Class II 2010-05-07
K100056 MEDCOM RT-VIEWER SYSTEM Medcom GmbH MUJ Class II 2010-05-07
K100830 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2010-05-05
K101041 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ITX Class II 2010-04-30
K100292 CAAS QVA 3D, CAAS QCA 3D Pie Medical Imaging BV LLZ Class II 2010-04-30
K093857 C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES Lightlab Imaging, Inc. NQQ Class II 2010-04-30
K094064 ILUMA VISION MODEL VERSION 2.2 3M Imtec LLZ Class II 2010-04-30
K100838 ERGO IMAGING SYSTEM Digirad Corp. IYX Class I 2010-04-23
K100449 MINXRAY MODEL CMDR-2S Minxray, Inc. IZL Class II 2010-04-23
K100113 VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 Sentinelle Medical, Inc. MOS Class II 2010-04-22
K094038 COMPACT TOUCH Quantel S.A. IYO Class II 2010-04-22
K100096 LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART Integra Radionics, Inc. IYE Class II 2010-04-22
K100400 PRESTODR PORTABLE Cmt Medical Technologies, Ltd. IZL Class II 2010-04-22
K100881 SYNAPSE OBLIQUUS MIP/MPR/FUSION Fujifilm Medical System U.S.A., Inc. LLZ Class II 2010-04-14
K100252 MASTER-VU A-SCAN, MV4500 Sonomed, Inc. IYO Class II 2010-04-09
K100264 T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 Bionix Development Corp. IYE Class II 2010-04-09
K100335 ORS VISUAL Object Research Systems, Inc. LLZ Class II 2010-04-08
K100417 XKNIFE 5 Integra Radionics, Inc. MUJ Class II 2010-04-08
K100692 DIGITAL SPOT MAMMOGRAPHY SYSTEM Hologic, Inc. IZH Class II 2010-04-06
K100164 MR INSPIRE WITH EXTENDED KIT Paramed S.R.L. LNH Class II 2010-04-05
K093371 MODEL DGH 6000 SCANMATE A Dgh Technology, Inc. IYO Class II 2010-04-05
K093790 SIMONDR DRP Simondr, Inc. MQB Class II 2010-04-05
K100670 S-SCAN, MODEL 9800020010 Esaote, S.p.A. MOS Class II 2010-04-05
K093706 PROXISCAN MODEL 101 Hybridyne Imaging Technologies, Inc. IYX Class I 2010-04-02
K100236 STAIR SYSTEMS PACS & DICOM VIEWER Stair Systems, Inc. LLZ Class II 2010-03-29
K100186 MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2010-03-24
K093984 PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 Time Medical Limited LNH Class II 2010-03-24
K093603 STORM-BASE 2.0 KARL STORZ Endoscopy-America, Inc. LLZ Class II 2010-03-18
K091631 ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW Aspyra, Inc. LLZ Class II 2010-03-18
K092363 SOFTVIEW, MODEL 2.01 Riverain Medical Group LLZ Class II 2010-03-18
K093044 OASIS MRI SYSTEM Hitachi Medical Systems America, Inc. LNI Class II 2010-03-16
K093485 VESISCAN Life-Tech, Inc. IYO Class II 2010-03-16
K092308 POLESTAR, MODEL N-30 Medtronic Navigation Israel, Ltd. LNH Class II 2010-03-16
K093066 I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 Infimed, Inc. OWB Class II 2010-03-16
K092427 SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) Albert Davydov Dds PC Professional LLZ Class II 2010-03-16
K100552 RAYSTATION VERSION 1.0 Raysearch Laboratories AB MUJ Class II 2010-03-12
K092922 SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER Sonoscape Company Limited IYN Class II 2010-03-12
K100094 CARESTREAM IMAGE SUITE Carestream Heatlh, Inc. LLZ Class II 2010-03-11
K093787 IGUIDE CAPPA Cas Innovations GmbH & Co. KG JAK Class II 2010-03-11
K100352 DIAGNOSOFT HARP MODEL 2.06 Diagnosoft, Inc. LNH Class II 2010-03-11
K100115 XVI R4.5 Elekta , Ltd. IYE Class II 2010-03-10
K100402 SITE-RITE VISION ULTRASOUND SYSTEM Bard Access Systems, Inc. IYN Class II 2010-03-05
K093336 INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM Medical Numerics, Inc. LNH Class II 2010-03-05
K092424 P-ART, MODEL 001 P-Cure, Ltd. IYE Class II 2010-03-05
K093480 CUATTRO UNOMD Cuattro, LLC LLZ Class II 2010-03-05
K093842 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS Invivo Corporation MOS Class II 2010-03-05
K092907 DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR Shantou Institute of Ultrasonic Instuments IYN Class II 2010-03-05
K090050 STEREOS WORKSTATION Biospace Med LLZ Class II 2010-03-05
K093612 SYNGO.PLAZA Siemens AG Medical Solutions LLZ Class II 2010-03-04
K093812 ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2010-03-03
K092613 COLOR LCD MONITOR, MODEL RADIFORCE RS210 Eizo Nanao Corporation LLZ Class II 2010-03-03
K100468 ZEISS INFRARED 800 WITH FLOW 800 OPTION Carl Zeiss Surgical GmbH IZI Class II 2010-03-03
K092842 ECHOPLAQUE Indec Systems, Inc. LLZ Class II 2010-03-01

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