meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2015-02-20

Clearances · page 49 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K150148 Terason uSmart3300 Ultrasound System Teratech Corp. IYN Class II 2015-02-20
K143122 Volcano iFR Harvest Software (Offline) Volcano Corporation IYO Class II 2015-02-20
K142597 Vienna System Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2015-02-19
K150097 GM60A-32S & GM60A-40S Samsung Electronics Co., Ltd. IZL Class II 2015-02-19
K143270 Optima XR646 Ge Hualun Medical Systems Co. , Ltd. KPR Class II 2015-02-18
K150122 TOMTEC-ARENA TTA2 Tomtec Imaging Systems GmbH LLZ Class II 2015-02-13
K142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems GE Healthcare IYN Class II 2015-02-10
K150050 ACUSON P500 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. IYN Class II 2015-02-09
K150145 MD322C8 31.5 Diagnostic Imaging LCD Monitor Nec Display Solutions , Ltd. PGY Class II 2015-02-06
K143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory Ninepoint Medical, Inc. NQQ Class II 2015-02-06
K143257 KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System Medicatech USA KPR Class II 2015-02-06
K143044 CAAS A-Valve Pie Medical Imaging BV LLZ Class II 2015-02-06
K143029 Digital Diagnostic X-ray System (GC80) Samsung Electronics Co., Ltd. KPR Class II 2015-02-04
K140828 NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE Brainreader Aps LLZ Class II 2015-02-04
K143251 SIGNA Creator, SIGNA Explorer Ge Healthcare (Ge Medical Systems, LLC) LNH Class II 2015-02-04
K141945 ECHOSTAR COMFORT 1.5T MRI Alltech Medical Systems America, Inc. LNH Class II 2015-02-03
K142273 EmboGuide Philips Medical Systems Nederland B.V. OWB Class II 2015-01-30
K143232 Universal Digital Interface 2W, UDI 2W Meridian Medical Systems, LLC MQB Class II 2015-01-30
K142714 S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System Sonoscape Company Limited IYN Class II 2015-01-29
K143281 Ultimax-i Toshibamedical Systems Corporation OWB Class II 2015-01-29
K143452 LOGIQ P9, LOGIQ P7 GE Healthcare IYN Class II 2015-01-29
K142815 S22 Digital Color Doppler Ultrasound System Sonoscape Company Limited IYN Class II 2015-01-28
K142222 NewTom 5G Qr S.R.L. JAK Class II 2015-01-26
K143000 RIS500 Ray Co., Ltd. MQB Class II 2015-01-23
K143396 omni TRAX Active Patient Tracker Civco Medical Instruments CO Inc Dba Civco Medical Solutions IYO Class II 2015-01-23
K143718 Mammography Color Display DP-M3010 Canon, Inc. PGY Class II 2015-01-22
K142773 EOS System Eos Imaging KPR Class II 2015-01-22
K133959 PODIATRY X-RAY SYSTEM Source-Ray, Inc. KPR Class II 2015-01-22
K142107 ECHO TRUE 3D VIEWER Echopixel, Inc. LLZ Class II 2015-01-21
K141561 VM PACS WITH VM MEDICAL WORKSTATION Visual Medica LLZ Class II 2015-01-16
K143298 Ultrasound Scanner System bk2300 Bk Medical Aps IYN Class II 2015-01-16
K142584 iMAR Siemens Medical Solutions USA, Inc. JAK Class II 2015-01-16
K142475 EVS 4343 DRTECH Corporation MQB Class II 2015-01-15
K142368 NOBLUS DIAGNOSTIC ULTRASOUND SCANNER Hitachi Aloka Medical, Ltd. IYN Class II 2015-01-14
K143493 SignosRT Bladder Ultrasound System Signostics, Ltd. IYO Class II 2015-01-14
K143223 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT Toshibamedical Systems Corporation JAK Class II 2015-01-12
K143225 INFX-8000V with Wireless Footswitch Toshibamedical Systems Corporation OWB Class II 2015-01-09
K142850 McKesson Radiology Mammography Plus Mckesson Medical Imaging Company LLZ Class II 2015-01-06
K142316 IMPAX Agility Agfa Healthcare N.V. LLZ Class II 2015-01-06
K140587 MR-CT VVA Medis Medical Imaging Systems BV LLZ Class II 2015-01-06
K142710 S9 Portable Digital Color Doppler Ultrasound System Sonoscape Company Limited IYN Class II 2015-01-05
K143472 TE7 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2015-01-02
K142697 NExCT 7 Neurologica Corporation JAK Class II 2014-12-23
K142701 SMD Sr90-1 Radionuclide Brachytherapy Source Salutaris Medical Devices, Inc. KXK Class II 2014-12-19
K143224 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. IYE Class II 2014-12-19
K142474 S12 Digital Color Doppler Ultrasound System Sonoscape Company Limited IYN Class II 2014-12-19
K142049 MULTIX FUSION VA30 & VA40 Siemens Medical Solutions USA, Inc. KPR Class II 2014-12-18
K142514 UniWeb 8.0 Ebm Technologies Incorporated LLZ Class II 2014-12-18
K142631 Hermes Medical Imaging Suite v5.5 Hermes Medical Solutions AB KPS Class II 2014-12-18
K142891 HEPATIQ Hepatiq, LLC LLZ Class II 2014-12-17
K142997 RTHawk, HeartVista Workstation with RTHawk Heartvista, Inc. LNH Class II 2014-12-17
K142492 GM60A-32S, GM60A-40S Samsung Electronics Co., Ltd. IZL Class II 2014-12-17
K142718 Radlink GPS Radlink, Inc. MQB Class II 2014-12-17
K142919 EXA Viztek, LLC LLZ Class II 2014-12-16
K140860 ImmersiveTouch3 and MicrovisTouch Immersivetouch LLZ Class II 2014-12-16
K142108 RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS Brainlab AG MUJ Class II 2014-12-16
K142944 ArthroPlan Digital Templating Software Arthromeda, Inc. LLZ Class II 2014-12-16
K142329 BBS REVOLUTION Dbmedx, Inc. IYO Class II 2014-12-15
K140797 IPACS MEDICAL IMAGE MANAGEMENT SYSTEM Visbion Limited LLZ Class II 2014-12-12
K142560 Varian Head Frame Varian Medical Systems, Inc. IYE Class II 2014-12-11
K142951 MD210C3 21.3 Diagnostic Imaging LCD Monitor Nec Display Solutions , Ltd. PGY Class II 2014-12-10
K143254 eSie Apps Suite Siemens Medical Solutions USA, Inc. LLZ Class II 2014-12-10
K143264 H60 V2.00 Diagnostic Ultrasound System Samsung Medison Co., Ltd. IYN Class II 2014-12-09
K142126 EP NAVIGATOR REL. 5.0 Philips Medical Systems Nederland B.V. OWB Class II 2014-12-09
K142431 WaterProof PROFILER Sun Nuclear Corporation IYE Class II 2014-12-05
K142361 Discovery MR750 3.0T Ge Medical Systems, LLC LNH Class II 2014-12-05
K142142 QUALITY REPORTS Sun Nuclear Corporation IYE Class II 2014-12-05
K142676 Siemens 3.0T PROCURE Array Coil Resonance Innovations, LLC MOS Class II 2014-12-05
K141701 I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] Isoaid, LLC KXK Class II 2014-12-05
K142671 ONEFIT HIP PLANNER Onefit Medical LLZ Class II 2014-12-05
K143079 Endovascular Stent Planning Software Vital Images, Inc. LLZ Class II 2014-12-04
K140920 SYNGO.CT COLONOGRAPHY Siemens Medical Solutions USA, Inc. NWE Class II 2014-12-03
K133496 X TWIN SYSTEM Roesys GmbH KPR Class II 2014-12-03
K133373 CLEARVIEW Neusoft Medical Systems Co., Ltd. JAK Class II 2014-12-03
K142521 Synapse 3D Liver and Kidney Analysis Fujifilm Meidcal Systems U.S.A.,Inc. LLZ Class II 2014-12-01
K140041 ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM Genoray Co., Ltd. OWB Class II 2014-11-28
K141741 AQUILION PRIME, V6.00 Toshibamedical Systems Corporation JAK Class II 2014-11-26
K143089 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. IYN Class II 2014-11-26
K133434 GENESIS II Dornier Medtech America, Inc. JAA Class II 2014-11-26
K142802 Atlas SPEEDER Head/Neck Quality Electrodynamics, LLC MOS Class II 2014-11-24
K142098 SIGNA PET/MR Ge Medical Systems, LLC OUO Class II 2014-11-24
K143261 2.3MP Color LCD Monitor, RadiForce MX242W Eizo Corporation PGY Class II 2014-11-21
K142197 ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 Konica Minolta, Inc. IYN Class II 2014-11-21
K142434 ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 Siemens Medical Solutions USA, Inc. IYE Class II 2014-11-21
K133674 PHILIPS IQON SPECTRAL CT Philips Healthcare (Cleveland) JAK Class II 2014-11-21
K142668 Lesion-Loc Iodine I-125 Seed/Needle Intramedical Imaging, LLC KXK Class II 2014-11-21
K143027 Xario 200, V3.0 Toshibamedical Systems Corporation IYN Class II 2014-11-20
K142100 AIXPLORER Supersonic Imagine IYN Class II 2014-11-20
K143046 Xario 100, V3.0 Toshibamedical Systems Corporation IYN Class II 2014-11-19
K141977 MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL Siemens Medical Solutions USA, Inc. LNH Class II 2014-11-19
K141462 VARIA-NCI Neurochaos Solutions, Inc. IYN Class II 2014-11-19
K143156 Sentinella 102; Sentinella 102 Horus General Equipment For Medical Imaging (Oncovision- IYX Class I 2014-11-18
K141958 ERB ENDORECTAL BALLOON Edge Medical, LLC PCT Class II 2014-11-18
K143098 3MP Color LCD monitor, RadiForce RS340 Eizo Corporation PGY Class II 2014-11-18
K142243 LessRay with Tracking Saferay Spine, LLC OWB Class II 2014-11-18
K131973 UNEXEF-38G ULTRASOUND SYSTEM Toyota Tsusho Corporation IYN Class II 2014-11-18
K133643 SYNGO, CT LIVER ANALYSIS Siemens Medi Cal Solutions, Inc. JAK Class II 2014-11-13
K142219 GammaBeam 100 Best Theratronics Limited IWB Class II 2014-11-13
K143076 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) Jvckenwood Corporation PGY Class II 2014-11-12
K143157 Coronis Fusion 4MP LED Barco N.V. PGY Class II 2014-11-12

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