meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
21
Latest Decision
2016-10-20

Clearances · page 43 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K161674 QuantumCam Ddd-Diagnostic A/S KPS Class II 2016-10-20
K161540 Advanced Breast Template System Varian Medical Systems, Inc. JAQ Class II 2016-10-20
K162629 IQM Integral Quality Monitor (also IQM) Irt Systems IYE Class II 2016-10-20
K162065 Ultrasound System SONIMAGE HS1 Konica Minolta, Inc. IYN Class II 2016-10-19
K162025 IntelliSpace Portal Platform Philips Medical Systems Nederlands B.V. LLZ Class II 2016-10-18
K160559 NOBLUS™ Ultrasound Diagnostic System Hitachi Medical Corporation IYN Class II 2016-10-18
K162029 16ch T/R Knee Coil Quality Electrodynamics, LLC MOS Class II 2016-10-18
K161960 bk2300 Bk Medical Aps IYN Class II 2016-10-17
K162614 Infinix, INFX-8000V, V6.35 Toshibamedical Systems Corporation OWB Class II 2016-10-17
K160371 NovaPACS Novarad Corporation LLZ Class II 2016-10-14
K162290 MyLabSix CrystaLine Esaote, S.p.A. IYN Class II 2016-10-14
K162011 MedDream Softneta Uab LLZ Class II 2016-10-14
K162487 BSD3543 Digital Flat Panel X-ray Detector Bontech, Inc. MQB Class II 2016-10-14
K160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray System Ecotron Co., Ltd. OWB Class II 2016-10-14
K161109 iSR'obot MRI-US Fusion Biobot Surgical Pte., Ltd. LLZ Class II 2016-10-06
K161937 CuattroDR Cuattro, LLC KPR Class II 2016-10-06
K161976 Ziehm Solo FD Ziehm Imaging GmbH OWB Class II 2016-10-06
K162519 1717WCC / 1717WGC Rayence Co., Ltd. MQB Class II 2016-10-06
K162518 1012WCC, 1012WGC Rayence Co., Ltd. MQB Class II 2016-10-06
K160666 Dentiq3D 3D Industrial Imaging Co., Ltd. LLZ Class II 2016-10-05
K153539 RS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. IYN Class II 2016-10-03
K162549 Lumify Ultrasound System Philips Health Care IYN Class II 2016-10-03
K161881 PreXion3D Excelsior Prexion Corporation OAS Class II 2016-10-03
K161828 kneeEOS Onefit Medical LLZ Class II 2016-10-03
K162504 SKR 3000 Konica Minolta, Inc. MQB Class II 2016-10-03
K162269 Voluson E6, Voluson E8, Voluson E10 GE Healthcare IYN Class II 2016-10-03
K161576 Esophagus Bougie Set Varian Medical Systems, Inc. JAQ Class II 2016-10-02
K160140 DENTRIa series Hdx Will Corp. OAS Class II 2016-09-30
K162527 8MP Color LCD Monitor (C81W+) Shenzhen Beacon Display Technology Co., Ltd. PGY Class II 2016-09-30
K162187 Xario 100 Diagnostic Ultrasound System, V5.0 Toshibamedical Systems Corporation IYN Class II 2016-09-30
K162417 Acuson Freestyle Ultrasound System Siemens Medi Cal Solutions, Inc. IYN Class II 2016-09-28
K161984 Interlocked Circular Small Field Collimators, Elekta Integrated Aktina Medical Corporation IYE Class II 2016-09-27
K162224 ArtPix Mobile EZ2GO Cmt Medical Technologies, Ltd. KPR Class II 2016-09-22
K161368 DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Agfa Healthcare N.V. MQB Class II 2016-09-22
K161439 E-CUBE 11 Alpinion Medical Systems Co., Ltd. IYN Class II 2016-09-21
K162112 CAAS MRV Pie Medical Imaging BV LLZ Class II 2016-09-21
K161843 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 Toshibamedical Systems Corporation IYN Class II 2016-09-21
K162339 Scenium Siemens Medical Solutions USA, Inc. LLZ Class II 2016-09-21
K161625 PixelShine Algomedica LLZ Class II 2016-09-19
K162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR Eizo Corporation PGY Class II 2016-09-19
K162008 JiveX Visus Technology Transfer GmbH LLZ Class II 2016-09-16
K162079 TRILLIUM Oval Head Coil 32 Hitachi Medical Systems America, Inc. MOS Class II 2016-09-16
K161946 DoseCHECK Sun Nuclear Corporation IYE Class II 2016-09-16
K162329 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System Philips Health Care IYN Class II 2016-09-14
K162172 EBit Series Diagnostic Ultrasound System Chison Medical Imaging Co., Ltd. IYN Class II 2016-09-14
K162177 dS FootAnkle I6CH 1.5T Coil Invivo Corporation MOS Class II 2016-09-14
K161201 ClearRead CT Riverain Technologies, LLC OEB Class II 2016-09-09
K162337 Symbia 6.5 Siemens Medical Solutions USA, Inc. KPS Class II 2016-09-08
K162288 SonoSite iViz Ultrasound System FUJIFILM Sonosite, Inc. IYN Class II 2016-09-08
K161966 PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector Perkinelmer, Inc. MQB Class II 2016-09-08
K161895 2MP Color LCD Monitor CCL214 (CL21214) Jvckenwood Corporation PGY Class II 2016-09-08
K162221 ACUSON SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Ultrasound Group IYN Class II 2016-09-06
K161459 Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) Varian Medical Systems, X-Ray Products-Infimed MQB Class II 2016-09-06
K162267 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2016-09-06
K162243 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System Siemens Medi Cal Solutions, Inc. IYN Class II 2016-09-06
K161756 SyncVision System Volcano Corporation OWB Class II 2016-09-05
K162141 Restore PACS Xian Wingspan Electronic Technology Co., Ltd. LLZ Class II 2016-09-02
K161168 MyLabSix Ultrasound System Esaote Europe B.V. IYN Class II 2016-09-02
K153705 PROcedure Rehearsal Studio 3Dsystems, Simbionix Products LLZ Class II 2016-09-02
K161942 PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector Perkinelmer, Inc. MQB Class II 2016-09-01
K162178 CareView 1500P X-ray Flat Panel Detectors Careray Digital Medical System Co., Ltd. MQB Class II 2016-09-01
K161567 SIGNA Voyager GE Healthcare LNH Class II 2016-09-01
K161588 Vscan Extend GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC IYN Class II 2016-08-31
K162001 1.5T and 3.0T 16 CH GE Shoulder Coils Invivo Corporation MOS Class II 2016-08-31
K161397 MAGiC Ge Medical Systems, LLC LNH Class II 2016-08-31
K160723 OnSight 3D Extremity System Carestream Health, Inc. JAK Class II 2016-08-30
K162094 RS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. IYN Class II 2016-08-26
K160455 AneurysmFlow Philips Medical Systems Nederland B.V. OWB Class II 2016-08-25
K161196 SOMATOM Drive Siemens Medical Solutions USA, Inc. JAK Class II 2016-08-24
K161130 ResolutionMD Calgary Scientific, Inc. LLZ Class II 2016-08-24
K160632 Vantage Titan 1.5T, MRT-1510, V3.6 Software Toshibamedical Systems Corporation LNH Class II 2016-08-23
K162052 Sentinella 102, Sentinella 102 Horus General Equipment For Medical Imaging (Oncovision- IYX Class I 2016-08-18
K162045 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System FUJIFILM Sonosite, Inc. IYN Class II 2016-08-18
K152949 WebPAX Heart Imaging Technologies, LLC LLZ Class II 2016-08-17
K161019 Uroview FD Pausch Medical GmbH JAA Class II 2016-08-17
K161518 PACS CORE/ENCORE Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. LLZ Class II 2016-08-17
K161748 SUPRIA w/guideShot Option Hitachi Medical Systems America, Inc. JAK Class II 2016-08-17
K161396 SPEC Model M23 Source Production and Equipment Co., Inc. KXK Class II 2016-08-17
K160612 Sumitomo Proton Therapy System Sumitomo Heavy Industries, Ltd. LHN Class II 2016-08-17
K152126 UST-5550-R; UST-5536-R; L43K Hitachi Aloka Medical America, Inc. ITX Class II 2016-08-17
K162196 Dell UP3216Q with QUBYX PerfectLum bundle Qubyx Software Technologies, Inc. PGY Class II 2016-08-15
K153283 VivoSight Dx Topical OCT System Michelson Diagnostics, Ltd. NQQ Class II 2016-08-11
K161574 Discovery MI Ge Medical Systems, LLC KPS Class II 2016-08-11
K161575 Affirm Lateral Arm Upright Biopsy Accessory Hologic IZH Class II 2016-08-10
K161066 SpotLight CT Arineta , Ltd. JAK Class II 2016-08-10
K160147 CT TrueView Philips Medical Systems Nederland B.V. OWB Class II 2016-08-10
K160516 Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths Varian Medical Systems, Inc. JAQ Class II 2016-08-10
K161955 5D Viewer Samsung Medison Co., Ltd. LLZ Class II 2016-08-10
K152224 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) Ion Beam Application S.A. LHN Class II 2016-08-09
K161148 icobrain Icometrix LLZ Class II 2016-08-09
K160743 Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc. JAK Class II 2016-08-08
K160611 P-ARTIS P-Cure, Ltd. JAK Class II 2016-08-08
K160806 Verza Guidance System CIVCO Medical Instruments Co., Inc. ITX Class II 2016-08-05
K161706 Vivid iq Ge Medical Systems Ultrasound and Primary Care Diagnostics L IYN Class II 2016-08-05
K161224 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC IYN Class II 2016-08-05
K161113 QXLink Vieworks Co., Ltd. LLZ Class II 2016-08-05
K160284 JointPoint Jointpoint, Inc. LLZ Class II 2016-08-03
K160932 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd. MOS Class II 2016-08-01
K160937 Senolris GE Healthcare LLZ Class II 2016-08-01
K160414 Precision Point Biopsy Needle Guide Corbin Clinical Resources, LLC ITX Class II 2016-08-01

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