meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2016-04-07

Clearances · page 45 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K160351 CX50N, CX50YQS Wide Corporation PGY Class II 2016-04-07
K160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. IYN Class II 2016-04-06
K160734 SonoSite SII Ultrasound System FUJIFILM Sonosite, Inc. IYN Class II 2016-04-05
K160790 Acclarix LX8 Diagnostic Ultrasound System Edan Instruments, Inc. IYN Class II 2016-04-04
K160283 S45 Digital Color Doppler Ultrasound System Sonoscape Medical Corp. IYN Class II 2016-04-04
K153583 BioVision Plus Faxitron Bioptics, LLC MWP Class II 2016-04-01
K153486 Affirm Prone Biopsy System Hologic, Inc. IZH Class II 2016-04-01
K160258 X5 Digital Color Doppler Ultrasound System Sonoscape Medical Corp. IYN Class II 2016-04-01
K153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0 Toshibamedical Systems Corporation JAK Class II 2016-04-01
K151612 NewTom VGi evo Qr S.R.L. OAS Class II 2016-03-31
K153547 ECHELON Oval V 5.1 MRI System Hitachi Medical Systems America, Inc. LNH Class II 2016-03-31
K153447 MAGNETOM Spectra Siemens Medical Solutions USA, Inc. LNH Class II 2016-03-31
K160620 Visaris Vision® (Vision C, Vision U. Vision V, Vision X) Visaris D.O.O. Belgrade KPR Class II 2016-03-30
K160621 SIGNAPioneer GE Healthcare LNH Class II 2016-03-29
K153284 Synaptive ImageDrive Pro Synaptive Medical, Inc. LLZ Class II 2016-03-29
K151765 SOMATOM Perspective Siemens Medical Solutions USA, Inc. JAK Class II 2016-03-25
K160277 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 GE Medical Systems Ultrasound and Primary Care Diagnostics IYN Class II 2016-03-25
K152716 EV Insite System Psp Corporation LLZ Class II 2016-03-24
K153324 Ingenia 1.5T and Ingenia 1.5T S R5.2 Philips Medical Systems Nederlands B.V. LNH Class II 2016-03-22
K160120 D-SPECT Processing and Reviewing Workstation Spectrum Dynamics , Ltd. KPS Class II 2016-03-21
K160420 SpeqT Signostics Limited IYO Class II 2016-03-21
K153710 Tuxedo Digital Dental Sensor Led Dental, Inc. MQB Class II 2016-03-18
K151749 somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) Siemens Medical Solutions USA, Inc. JAK Class II 2016-03-18
K160524 FibroScan 530 Compact Echosens IYO Class II 2016-03-18
K153355 Xeleris 4.0 Processing and Review Workstation GE Healthcare LLZ Class II 2016-03-16
K160406 FUJIFILM FC1 Ultrasound System FUJIFILM Sonosite, Inc. IYN Class II 2016-03-16
K160150 Vitrea CT Colon Analysis Vital Images, Inc. LLZ Class II 2016-03-16
K153612 ArthrexVIP Web Portal Custom Orthopaedic Solutions, Inc. LLZ Class II 2016-03-15
K153119 Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, Summit Industries, LLC KPR Class II 2016-03-14
K151780 CAAS Workstation Pie Medical Imaging BV IZI Class II 2016-03-11
K160078 Vivid T8 Ge Medical Systems Ultrasound and Primary Care Diagnotics, L IYN Class II 2016-03-10
K153429 SmartView 3D Option Ge Hangwei Medical System Co., Ltd. JAK Class II 2016-03-09
K160381 TE7 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2016-03-09
K153270 TruGuard Custom Tongue and Jaw Positioner Bionix Development Corp. IYE Class II 2016-03-08
K153244 Cios Fusion Siemens Medical Solutions USA, Inc. OWB Class II 2016-03-07
K160301 Platinum dRF Imaging System Apelem-Dms Group JAA Class II 2016-03-04
K160426 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. LLZ Class II 2016-03-04
K153346 syngo Application Software VD11 Siemens Medical Solutions USA, Inc. LLZ Class II 2016-03-04
K153212 Sheathes Ultrasound Probe Covers Sheathing Technologies, Inc. ITX Class II 2016-03-04
K152602 Olea Sphere V3.0 Olea Medical LLZ Class II 2016-03-03
K160347 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 Qingdao Hisense Medical Equipment Co., Ltd. PGY Class II 2016-03-03
K160185 Wrist 3 Aspect Imaging, Ltd. LNH Class II 2016-03-01
K160317 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. LLZ Class II 2016-02-29
K152855 VIVIX-S 1012N Vieworks Co., Ltd. MQB Class II 2016-02-26
K153424 E-CUBE i7 Alpinion Medical Systems Co., Ltd. IYN Class II 2016-02-26
K152894 VIVIX-S 1717N Vieworks Co., Ltd. MQB Class II 2016-02-26
K160182 LOGIQ S7 Expert GE Healthcare IYN Class II 2016-02-26
K153091 IMPLANT 3D Media Lab S.R.L. LLZ Class II 2016-02-25
K160063 McLaren Proton Therapy System Mclaren Health Care Corporation LHN Class II 2016-02-25
K151737 MedicVOD System Orpheus Medical , Ltd. LLZ Class II 2016-02-25
K151435 MRCAT Philips Medical Systems MR Finland MUJ Class II 2016-02-25
K153570 Axxent Electronic Brachytherapy System Model 110 XP 1200 Icad, Inc. JAD Class II 2016-02-25
K160328 DIVA ZSP2105CMI with QUBYX PerfectLum bundle The Linden Group Corp PGY Class II 2016-02-25
K160184 Voluson S6, Voluson S8, Voluson S10 GE Healthcare IYN Class II 2016-02-25
K160326 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) Jvckenwood Corporation PGY Class II 2016-02-23
K152034 FS-PACS Ec-Web Co., Ltd. LLZ Class II 2016-02-23
K160247 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR Eizo Corporation PGY Class II 2016-02-23
K160315 I4 (Integrated Intelligent Imaging Informatics) system Philips Medical Systems Nederland B.V. LLZ Class II 2016-02-19
K153220 syngo.CT Single Source Dual Energy (Twin Beam) Siemens Medical Solutions USA, Inc. JAK Class II 2016-02-19
K143290 DBSWIN and VistaEasy Imaging Software Durr Dental AG LLZ Class II 2016-02-18
K153593 CliniscanSM MRI Picofemto, LLC LLZ Class II 2016-02-17
K153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System Ninepoint Medical, Inc. NQQ Class II 2016-02-16
K153368 Radiance V3 Gmv Soluciones Globales Internet S.A.U. MUJ Class II 2016-02-16
K153004 Clear Guide SCENERGY Clear Guide Medical JAK Class II 2016-02-12
K160001 TraumaCad Mobile Release 2.0 Voyant Health, Ltd. LLZ Class II 2016-02-12
K153103 CARESTREAM Vue PACS Carestream Health, Inc. LLZ Class II 2016-02-12
K153232 Cios Select Siemens Medical Solutions USA, Inc. OWB Class II 2016-02-10
K152489 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray Panoramic Corp. OAS Class II 2016-02-04
K152994 Adaptivo Aurora Technology Development, LLC IYE Class II 2016-02-03
K160108 Synapse PACS Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2016-02-03
K153529 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. IYN Class II 2016-02-02
K153059 HF1202H PowerPlus Portable X-ray Equipment Minxray, Inc. IZL Class II 2016-02-02
K153416 ArcScan Insight 100 Arcscan, Inc. IYO Class II 2016-02-02
K151426 ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ Scandidos AB IYE Class II 2016-01-29
K153166 Fusion Bx Focal Healtcare, Inc. LLZ Class II 2016-01-25
K152503 ImagenSPECT Cardiovascular Imaging Technologies KPS Class II 2016-01-25
K152977 DG PACS Dicom Grid, Inc. LLZ Class II 2016-01-25
K153402 Discovery NM/CT 670 CZT GE Healthcare KPS Class II 2016-01-21
K153421 HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS Hitachi Aloka Medical America, Inc. IYN Class II 2016-01-21
K152473 CAS-One IR Cascination AG JAK Class II 2016-01-20
K153626 SonoSite Edge II Ultrasound System FUJIFILM Sonosite, Inc. IYN Class II 2016-01-20
K152352 Stereo 3D option for Vision Applications GE Medical Systems SCS LLZ Class II 2016-01-20
K152584 Stroke VCAR GE Medical Systems SCS JAK Class II 2016-01-20
K151075 BR-ABVS Viewer 1.0 Taihao Medical, Inc. LLZ Class II 2016-01-15
K153289 HEALTHMYNE Healthmyne, Inc. LLZ Class II 2016-01-15
K152697 INFX-8000C, V6.20 Toshibamedical Systems Corporation OWB Class II 2016-01-15
K152854 S50 Digital Color Doppler Ultrasound System Sonoscape Medical Corp. IYN Class II 2016-01-13
K151070 Sonishield 100 Antimicrobial Ultrasound Gel Quotient Medical MUI Class II 2016-01-13
K152880 Biograph Horizon PET/CT Siemens Medical Solutions USA, Inc. KPS Class II 2016-01-12
K152696 INFX-8000V, V6.20 Toshibamedical Systems Corporation OWB Class II 2016-01-12
K151152 ImplantMax Software Saturn Imaging, Inc. LLZ Class II 2016-01-12
K153354 3MP Color LCD Monitor, RadiForce RX350 Eizo Corporation PGY Class II 2016-01-12
K153147 Cios Connect Siemens Medical Solutions USA, Inc. OWB Class II 2016-01-12
K153039 MRI Dynamic Analysis Plus Esaote, S.p.A. LNH Class II 2016-01-08
K153427 Volpara Imaging Software Matakina Technology, Ltd. LLZ Class II 2016-01-07
K153037 LOGIQ V1/ LOGIQ V2 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC IYN Class II 2016-01-04
K152746 Ez3D Plus Ewoosoft Co., Ltd. LLZ Class II 2016-01-03
K153492 CareView 1800L Careray Digital Medical System Co., Ltd. MQB Class II 2015-12-24
K152283 MAGNETOM Amira Siemens Medical Solutions USA, Inc. LNH Class II 2015-12-24
K153369 SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz Volcano Corporation IYO Class II 2015-12-22

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