meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
24
Latest Decision
2017-05-04

Clearances · page 41 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K171130 Nucleus Image Management System Nucleushealth, LLC LLZ Class II 2017-05-04
K171098 AXIS Image Management System Sonomed, Inc. NFJ Class II 2017-05-02
K163119 NaviSuite SSI Edition Medcom GmbH LLZ Class II 2017-05-01
K170975 Televere Digital Imaging System Televere Systems MQB Class II 2017-05-01
K162647 NuVasive NuvaLine Mobile App Nu Vasive, Incorporated LLZ Class II 2017-05-01
K161724 Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) Radiomed Corporation IYE Class II 2017-04-28
K170952 syngo.CT View&GO Siemens Medical Solutions USA, Inc. LLZ Class II 2017-04-28
K170273 Z-DOSE29 Zetta Medical Technologies, LLC JAK Class II 2017-04-28
K170949 RadiForce MX315W Eizo Corporation PGY Class II 2017-04-27
K170930 RSM 2430C DRTECH Corporation MUE Class II 2017-04-27
K170069 AmCAD-UV Amcad Biomed Corporation LLZ Class II 2017-04-26
K162799 Cliniview Palodex Group OY LLZ Class II 2017-04-25
K170858 FDR AQRO (DR-XD 1000) Fujifilm Medical Systems U.S.A, Inc. IZL Class II 2017-04-24
K170716 PercuNav Image Fusion and Interventional Navigation Philips Ultrasound, Inc. JAK Class II 2017-04-21
K170221 syngo.CT Cardiac Planning Siemens Healthcare GmbH JAK Class II 2017-04-21
K163690 DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2017-04-20
K162722 HyperSense Ge Medical Systems, LLC LNH Class II 2017-04-20
K163443 Interson USB Ultrasound System Interson Corporation IYN Class II 2017-04-13
K170502 Patient Positioning System Forte Automation Systems, Inc. JAI Class II 2017-04-13
K170580 Carestream Vue PACS Carestream Health, Inc. LLZ Class II 2017-04-11
K170788 CyberKnife Treatment Delivery System Accuray Incorportaed IYE Class II 2017-04-11
K170445 LOGIQ S8 GE Healthcare IYN Class II 2017-04-11
K163192 Comfort EC710 Alltech Medical Systems America, Inc. LNH Class II 2017-04-10
K170813 ORTHOPANTOMOGRAPH OP 3D Palodex Group OY OAS Class II 2017-04-07
K162838 Philips iCT CT System Philips Medical Systems (Cleveland), Inc. JAK Class II 2017-04-07
K162287 Synapse 3D Perfusion Analysis Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2017-04-06
K170385 CORE M2 Vascular System Volcano Corporation IYO Class II 2017-04-06
K161829 Huvitz Imaging System Huvitz Co., Ltd. NFJ Class II 2017-04-06
K163711 IQon Spectral CT Philips Medical Systems (Cleveland), Inc. JAK Class II 2017-04-05
K163076 Segment CMR Medviso AB LLZ Class II 2017-04-05
K161919 UltraScan 650 Cyberlogic, Inc. MUA Class II 2017-04-05
K170837 Nio Color 3MP (MDNC-3421) Barco N.V. PGY Class II 2017-04-05
K161341 LIFESYS PACS Lifetrack Medical Systems, Inc. LLZ Class II 2017-04-05
K170719 Anzai Respiratory Gating System Anzai Medical Co., Ltd. LHN Class II 2017-04-05
K170315 Acuson SC2000 Diagnostic Ultrasound System Siemens Medi Cal Solutions, Inc. IYN Class II 2017-04-04
K170781 MX50N(MX50YQS) Wide Corporation PGY Class II 2017-04-04
K162559 Move Forward 3D Motion Simulation Service Biomet, Inc. LLZ Class II 2017-03-31
K170783 CX50N(CX50YQS) Wide Corporation PGY Class II 2017-03-31
K170493 HS50 / HS60 Diagnostic Ultrasound System Samsung Medison Co., Ltd. IYN Class II 2017-03-28
K170476 Nio Color 5.8MP (MDNC-6121) Barco N.V. PGY Class II 2017-03-28
K162615 Mould Applicator Set Varian Medical Systems, Inc. JAQ Class II 2017-03-24
K163290 INFINITT ULite Infinitt Co., Ltd. LLZ Class II 2017-03-24
K163297 Scan&GO Siemens Medical Solutions USA, Inc. JAK Class II 2017-03-24
K170277 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2017-03-23
K163296 SOMATOM go.Up, SOMATOM go.Now Siemens Medical Solutions USA, Inc. JAK Class II 2017-03-21
K163405 360KS Implant Positioning System Kico Knee Innovation Company Pty Limited LLZ Class II 2017-03-21
K163157 SmartGrid Carestream Health MQB Class II 2017-03-21
K162868 Exam Vue PACS Jpi Healthcare Solutions, Inc. LLZ Class II 2017-03-17
K163331 Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist Ge Medical Systems, LLC LNH Class II 2017-03-17
K170451 FDX Console (DR-ID300CL) Software Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2017-03-16
K163082 6200 Ultrasound System and 6250 Ultrasound System Esaote, S.p.A. IYN Class II 2017-03-16
K163572 LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source Lv Liberty Vision Corp. KXK Class II 2017-03-15
K160815 Interstitial Needles Varian Medical Systems, Inc. JAQ Class II 2017-03-10
K163286 ARTIS pheno Siemens Medical Solution USA, Inc. OWB Class II 2017-03-09
K162394 CRC-77tHR Capintec, Inc. KPT Class II 2017-03-08
K162529 DigiX FDX Allengers Medical Systems Limited KPR Class II 2017-03-03
K170167 True 3D Viewer Software Echopixel, Inc. LLZ Class II 2017-03-03
K163528 HITACHI Supria Whole-body X-ray CT System Phase 3 Hitachi Medical Systems America, Inc. JAK Class II 2017-03-03
K170058 TheraView TBI Cablon Medical B.V. IYE Class II 2017-03-03
K170355 RayStation 6 RaySearch Laboratories AB (PUBL) MUJ Class II 2017-03-02
K170332 DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS Canon, Inc. MQB Class II 2017-03-01
K163284 syngo. CT Neuro Perfusion Siemens Medical Solutions USA, Inc. JAK Class II 2017-03-01
K163234 Biograph mMR with syngo MR E11P system software Siemens Medical Solutions USA, Inc. OUO Class II 2017-02-28
K162018 Surface Applicator Set Varian Medical Systems, Inc. JAQ Class II 2017-02-28
K162393 The ViewRay (MRIdian) Linac System Viewray, Incorporated IYE Class II 2017-02-24
K160857 HF 718BD X-Ray System Arquilla, Inc. Dba X-Cel X-Ray Corporation KPR Class II 2017-02-24
K163688 Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 Medisono, LLC IYN Class II 2017-02-23
K162484 Lung Nodule Assessment and Comparison Option (LNA) Philips Medical Systems Nederland B.V. LLZ Class II 2017-02-23
K162670 RSM 1824C with RConsole1 DRTECH Corporation MUE Class II 2017-02-23
K163691 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. IYN Class II 2017-02-22
K170202 Aquarius 8600 Imaging Dynamics Company , Ltd. MQB Class II 2017-02-22
K163619 SIGNA PET/MR Ge Medical Systems, LLC OUO Class II 2017-02-14
K162830 SIS Software Surgical Information Sciences, Inc. LLZ Class II 2017-02-14
K163285 syngo Application Software Siemens Medical Solution USA, Inc. LLZ Class II 2017-02-14
K160610 Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set Kobold, LLC JAQ Class II 2017-02-13
K163596 LOGIQ P9 and LOGIQ P7 GE Healthcare IYN Class II 2017-02-10
K163341 syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc. JAK Class II 2017-02-09
K170113 pixium 4343RCE Philips Medical Systems Dmc GmbH MQB Class II 2017-02-09
K170086 Pinnacle Radiation Therapy Planning System Philips Medical Systems (Cleveland), Inc. MUJ Class II 2017-02-09
K163289 syngo. CT Single Source Dual Energy (twin beam) Siemens Medical Solutions USA, Inc., Ultrasound DI JAK Class II 2017-02-09
K163703 VIVIX-S 1417N Vieworks Co., Ltd. MQB Class II 2017-02-08
K162039 OptosAdvance 4.0 Software Optos Plc. NFJ Class II 2017-02-08
K163294 syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology Siemens Medical Solutions USA, Inc. LLZ Class II 2017-02-06
K160934 UC-CARE NaviGo Workstation UC-CARE , Ltd. LLZ Class II 2017-02-06
K170019 Aquilion Lightning, TSX-036A/1, V8.4 Toshibamedical Systems Corporation JAK Class II 2017-02-02
K163122 NobelClinician, DTX Studio implant Nobel Biocare AB LLZ Class II 2017-01-31
K163210 Philips CombiDiagnost R90 Philips Medical Systems Dmc GmbH JAA Class II 2017-01-31
K162055 Acclarix LX8 Diagnostic Ultrasound System Edan Instruments, Inc. IYN Class II 2017-01-31
K163312 MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software Siemens Medical Solutions USA, Inc. LNH Class II 2017-01-27
K162909 CSX-30 Flat Panel Detector Canon, Inc. – Medical Equipment Group MQB Class II 2017-01-27
K163211 MAGNETOM Sempra with syngo MR E11S Siemens Medical Solutions USA, Inc. LNH Class II 2017-01-27
K161688 Advanced Gynecological Applicator Nucletron B.V. JAQ Class II 2017-01-27
K162285 EBM iDO Viewer 1.2.1 Ebm Technologies Incorporated LLZ Class II 2017-01-27
K163324 nordicBrainEx Nordicneurolab AS LLZ Class II 2017-01-27
K163715 Allura Xper R9 Philips Medical Systems Nederland B.V. OWB Class II 2017-01-26
K163281 FastStroke Gef Medical Systems Scs JAK Class II 2017-01-26
K163574 Multi Modality Viewer Vital Images, Inc. LLZ Class II 2017-01-26
K162472 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. IYE Class II 2017-01-19
K162651 Breast BI 7 MR Coil Mammavention 3T Moras Mri Products GmbH MOS Class II 2017-01-18
K163533 EzDent-i; E2; ProraView Ewoosoft Co., Ltd. LLZ Class II 2017-01-12

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