meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
26
Latest Decision
2017-01-12

Clearances · page 42 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K163205 48CH Head Coil Ge Healthcare Coils (Usa Instruments, Inc.) MOS Class II 2017-01-12
K163635 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. Ultrasound Group IYN Class II 2017-01-12
K163252 Mammomat Fusion with Stereotactic Biopsy Siemens Medical Solutions USA, Inc. MUE Class II 2017-01-10
K163120 EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. IYN Class II 2017-01-10
K161971 Bindex BI-2 Bone Index Finland , Ltd. MUA Class II 2017-01-09
K162483 Symbia Intevo Bold Siemens Medical Solutions USA, Inc. KPS Class II 2017-01-09
K161841 D2P 3D Systems, Inc. LLZ Class II 2017-01-09
K163116 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Philips Medical Systems Nederland B.V. LNH Class II 2017-01-06
K162946 8ch Knee-Foot SPEEDER Quality Electrodynamics, LLC MOS Class II 2017-01-06
K162931 Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 Philips Medical Systems Nederland B.V. LNH Class II 2017-01-06
K163013 Quantib Brain 1.2 Quantib B.V. LLZ Class II 2017-01-06
K163253 Arterys Cardio DL Arterys, Inc. LLZ Class II 2017-01-05
K163410 DigitalDiagnost C50 Philips Healthcare (Suzhou) Co., Ltd. KPR Class II 2017-01-04
K163429 B6 Beijing East Whale Imaging Technology Co., Ltd. OXO Class II 2017-01-04
K161270 CephSimulation Anatomage, Inc. LLZ Class II 2017-01-04
K163396 ACUSON P500 Ultrasound System Siemens Medical Solutions USA, Inc. IYN Class II 2017-01-04
K163421 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. LLZ Class II 2017-01-03
K163427 X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System Sonoscape Medical Corp. IYN Class II 2017-01-03
K162940 MultiBand SENSE Philips Medical Systems Nederland B.V. LNH Class II 2016-12-30
K161959 ClearView cCAD Clearview Diagnostics, Inc. LLZ Class II 2016-12-28
K163539 Ez3D-i / E3 Ewoosoft Co., Ltd. LLZ Class II 2016-12-23
K162555 EVS 4343, EVS 4343G DRTECH Corporation MQB Class II 2016-12-21
K162344 INNOLUX RIC Innolux Corporation MQB Class II 2016-12-20
K162955 Multi-Modality Tumor Tracking (MMTT) application Philips Medical Systems Nederland B.V. LLZ Class II 2016-12-19
K162302 Somatom Confidence ® RT Pro Siemens Medical Solutions USA, Inc. JAK Class II 2016-12-16
K163213 Revolution CT Ge Medical Systems, LLC JAK Class II 2016-12-16
K163335 6MP Color LCD Monitor, RadiForce RX660, RX660-AR Eizo Corporation PGY Class II 2016-12-15
K162845 DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2016-12-15
K163206 SMD-Sr90-DA Radionuclide Brachytherapy Source Salutaris Medical Devices, Inc. KXK Class II 2016-12-15
K162568 INTRABEAM 600 Carl Zeiss Meditec, AG JAD Class II 2016-12-15
K162902 ARIETTA Prologue Diagnostic Ultrasound system and Transducers Hitachi , Ltd. IYN Class II 2016-12-15
K160852 Zia Zetta Medical Technologies, LLC LLZ Class II 2016-12-15
K163203 Carestream DRX-Evolution Carestream Health, Inc. KPR Class II 2016-12-13
K162476 Varian High Energy Linear Accelerator Varian Medical Systems, Inc. IYE Class II 2016-12-12
K163063 UC-5000 Mobile X-Ray Source-Ray, Inc. IZL Class II 2016-12-12
K161900 HYPERION X5 Cefla S.C. OAS Class II 2016-12-09
K162623 16ch T/R Hand Wrist Coil Quality Electrodynamics, LLC MOS Class II 2016-12-09
K161730 Wireless Digital Flat Panel Detector Iray Technology (Shanghai) , Ltd. MQB Class II 2016-12-08
K161400 ImagingRing System Medphoton GmbH IYE Class II 2016-12-08
K162376 CAAS MR 4D Flow Pie Medical Imaging BV LLZ Class II 2016-12-08
K162246 ProNova SC360 Proton Therapy System Pronova Solutions, LLC LHN Class II 2016-12-08
K163115 GC70 Samsung Electronics Co., Ltd. KPR Class II 2016-12-07
K161322 CT CoPilot Zepmed, LLC LLZ Class II 2016-12-07
K152009 DENSEEMAMMO v1.0 Statlife LLZ Class II 2016-12-05
K162972 ExactVu High Resolution Micro-Ultrasound System Exact Imaging IYO Class II 2016-12-02
K161682 GE Lunar DXA Bone Densitometers with enCORE version 17 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC KGI Class II 2016-12-02
K162859 Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V. OWB Class II 2016-12-02
K152813 FS-500DDR Medical Radiographic X-Ray System Orich Medical Equipment (Tianjin) Co., Ltd. KPR Class II 2016-12-02
K163158 MEDSYNAPSE Zero Footprint Viewer Medsynaptic Private, Ltd. LLZ Class II 2016-12-02
K162552 EVS 3643, EVS 3643G DRTECH Corporation MQB Class II 2016-12-02
K162468 ClearCheck Radformation IYE Class II 2016-12-01
K163019 CareView 750Cw/750C X-ray Flat Panel Detectors Careray Digital Medical System Co., Ltd. MQB Class II 2016-12-01
K163138 Clarius Ultrasound System Clarius Mobile Health Corp. IYN Class II 2016-11-30
K162966 TxRx Knee 15 Flare MR Coil 1.5T Quality Electrodynamics, LLC MOS Class II 2016-11-30
K162466 LuminScan (TM) Imaging System Micro-Tech (Nanjing) Co., Ltd. NQQ Class II 2016-11-29
K163066 TxRx Knee 15 Flare MR Coil 3.0T Quality Electrodynamics, LLC MOS Class II 2016-11-29
K162183 Vantage Galan 3T, MRT-3020, V4.0 Toshibamedical Systems Corporation LNH Class II 2016-11-25
K162148 Allura Xper R9 Philips Medical Systems Nethrlands BV OWB Class II 2016-11-23
K162102 MAGNETOM Avantofit, MAGNETOM Skyrafit Siemens Medi Cal Solutions, Inc. LNH Class II 2016-11-22
K162971 Multix Fusion Max Siemens Medical Solutions USA, Inc. KPR Class II 2016-11-22
K162355 Raycast MammoRx Carbon Fibre Breast Board Orfit Industries NV IYE Class II 2016-11-22
K162743 ViewPoint 6 GE Medical Systems Ultrasound and Primary Care Diagnostics LLZ Class II 2016-11-22
K160933 Discovery NM 750b Bopsy GE Healthcare IYX Class I 2016-11-18
K162403 HyperBand Ge Medical Systems, LLC LNH Class II 2016-11-18
K161795 MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc. LNH Class II 2016-11-18
K162577 Dosimetry Check Version 5 Release 1 Math Resolutions, LLC IYE Class II 2016-11-18
K160045 Heyman Packing Applicator Set Varian Medical Systems, Inc. JAQ Class II 2016-11-17
K162583 ALOKA LISENDO 880 Hitachi , Ltd. IYN Class II 2016-11-17
K163077 LOGIQ E9, LOGIQ E9 XDClear 2.0 GE Medical Systems Ultrasound and Primary Care Diagnostics IYN Class II 2016-11-17
K161999 Aixplorer Supersonic Imagine IYN Class II 2016-11-16
K162541 syngo Application Software Siemens Medical Solutions USA, Inc. LLZ Class II 2016-11-16
K163020 Xperius Ultrasound System Philips Health Care IYN Class II 2016-11-16
K162278 Digital Diagnostic Mobile X-ray System Samsung Electronics Co., Ltd. IZL Class II 2016-11-15
K162265 CushionCast Moldable Cushions Izi Medical Products, LLC IYE Class II 2016-11-15
K162990 Optima XR240amx Ge Medical Systems, LLC IZL Class II 2016-11-15
K160166 X-MIND trium De Gotzen S.R.L. OAS Class II 2016-11-15
K161515 eUnity Client Outlook, Inc. LLZ Class II 2016-11-15
K162085 i-CAT FLX V series / KaVo 3D eXam+ V series Imaging Sciences International OAS Class II 2016-11-10
K161634 IPS CaseDesigner Nobel Biocare AB LLZ Class II 2016-11-10
K162862 Raycast High Precision Lung Board Solution Orfit Industries NV IYE Class II 2016-11-09
K162863 dS Small Extremity 16CH 1.5T Coil Invivo Therapeutics Corporation MOS Class II 2016-11-07
K161740 D-SPECT Scanner, D-SPECT L Scanner Spectrum Dynamics Medical, Ltd. KPS Class II 2016-11-04
K162573 Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source Source Production and Equipment Co., Inc. KXK Class II 2016-11-04
K161968 MicrUs Telemed IYO Class II 2016-11-03
K162268 Senographe Pristina GE Healthcare MUE Class II 2016-11-03
K160921 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant Cs Medical, LLC PSW Class II 2016-11-03
K161157 Vitrea CT Dual Energy Image View Vital Images, Inc. JAK Class II 2016-11-03
K162002 Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay Zdi, Solutions, LLC IYE Class II 2016-11-01
K162155 Xario 200 Diagnostic Ultrasound System V5.0 Toshibamedical Systems Corporation IYN Class II 2016-11-01
K160882 PaX-i3D Green Premium (Model: PCT-90LH) VATECH Co., Ltd. OAS Class II 2016-10-28
K162513 Arterys Software v2.0 Arterys, Inc. LLZ Class II 2016-10-28
K160143 ClearVision ExamVue Flat Panel Detector Jpi Healthcare, Inc. MQB Class II 2016-10-28
K162370 syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. MUJ Class II 2016-10-25
K161973 G-scan Brio, S-scan Esaote, S.p.A. LNH Class II 2016-10-25
K162736 Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT Siemens Medical Solutions USA, Inc. KPS Class II 2016-10-25
K162145 vRad PACS with Mammography Virtual Radiologic Corporation LLZ Class II 2016-10-25
K162687 Paragon 2 Meridian Medical Systems, LLC IZL Class II 2016-10-21
K162474 Artemis Eigen LLZ Class II 2016-10-21
K160442 Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers Neural Analytics, Inc. IYN Class II 2016-10-21
K162660 Green Smart (Model: PHT-35LHS) VATECH Co., Ltd. OAS Class II 2016-10-20

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