Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 21
- Latest Decision
- 2017-07-19
Clearances · page 40 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K171812 | Nio Color 2MP (MDNC-2123) | Barco N.V. | PGY | Class II | 2017-07-19 |
| K170978 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | LNH | Class II | 2017-07-19 |
| K163687 | OLINDA EXM | Hermes Medical Solutions AB | IYX | Class I | 2017-07-19 |
| K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | MWP | Class II | 2017-07-18 |
| K170729 | Examion X-AQS | Examion GmbH | LLZ | Class II | 2017-07-18 |
| K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYO | Class II | 2017-07-18 |
| K171544 | Arterys Viewer | Arterys, Inc. | LLZ | Class II | 2017-07-18 |
| K170607 | !M1 | Solutions For Tomorrow AB | IZL | Class II | 2017-07-17 |
| K171115 | 3D Endo Software | Dentsply Sirona | LLZ | Class II | 2017-07-17 |
| K170090 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | LNH | Class II | 2017-07-14 |
| K171128 | SIGNA Premier | Ge Medical Systems, LLC | LNH | Class II | 2017-07-14 |
| K171733 | TrueBeam, TrueBeam STx, Edge | Varian Medical Systems, Inc. | IYE | Class II | 2017-07-12 |
| K171800 | OEC Elite MiniView | Ge Hualun Medical Systems Co. , Ltd. | OXO | Class II | 2017-07-12 |
| K170999 | P50 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2017-07-12 |
| K171766 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | IYO | Class II | 2017-07-12 |
| K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories | Qfix | IYE | Class II | 2017-07-11 |
| K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | Supersonic Imagine | IYN | Class II | 2017-07-11 |
| K171000 | P60 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2017-07-11 |
| K171034 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2017-07-10 |
| K170480 | Models 3543A, 4343A, 2929A and A843B | Shanghai PZ Medical Technolgoy Co., Ltd. | MQB | Class II | 2017-07-07 |
| K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | Philips Medical Systems Dmc GmbH | MQB | Class II | 2017-07-07 |
| K170870 | Site~Rite Halcyon Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | IYN | Class II | 2017-07-06 |
| K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | 2017-07-05 |
| K170239 | Leica FL560 | Leica Microsystems (Schweiz) AG | IZI | Class II | 2017-07-05 |
| K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | LLZ | Class II | 2017-07-03 |
| K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 | Toshibamedical Systems Corporation | JAK | Class II | 2017-06-30 |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) | Fujifilm Medical Systems U.S.A, Inc. | MQB | Class II | 2017-06-30 |
| K170817 | Halcyon | Varian Medical Systems, Inc. | IYE | Class II | 2017-06-27 |
| K171536 | RayStation | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2017-06-27 |
| K163668 | SUITESTENSA | Ebit Srl | LLZ | Class II | 2017-06-23 |
| K171591 | CUBEScan BioCon-900 (Bladder Volume Measurement System) | Mcube Technology Co., Ltd. | IYO | Class II | 2017-06-22 |
| K170638 | Retina Workplace | Carl Zeiss Meditec, AG | NFJ | Class II | 2017-06-21 |
| K170755 | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. | IZL | Class II | 2017-06-21 |
| K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | IYN | Class II | 2017-06-21 |
| K171485 | BSD4343R Digital Flat Panel X-ray Detector | Bontech, Inc. | MQB | Class II | 2017-06-21 |
| K170909 | Infinix INFX-8000V, V6.40 | Toshiba Medical Systems Coroporation | OWB | Class II | 2017-06-16 |
| K170066 | Green16/Green18 (Model: PHT-65LHS) | VATECH Co., Ltd. | OAS | Class II | 2017-06-16 |
| K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK | Class II | 2017-06-14 |
| K170396 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2017-06-14 |
| K170847 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | LLZ | Class II | 2017-06-14 |
| K170878 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | IYN | Class II | 2017-06-14 |
| K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2017-06-12 |
| K171417 | 1417WGC_127um and 1417WGC_140um | Rayence Co., Ltd. | MQB | Class II | 2017-06-12 |
| K161354 | MELODY, Remote Control System for Ultrasound Probe | Adecho Tech | IYO | Class II | 2017-06-12 |
| K171418 | 1417WCC_127um and1417WCC_140um | Rayence Co., Ltd. | MQB | Class II | 2017-06-12 |
| K171437 | SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | IYN | Class II | 2017-06-12 |
| K170747 | syngo Application Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2017-06-09 |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | CIVCO Medical Instruments Co., Inc. | ITX | Class II | 2017-06-09 |
| K171420 | 1717SCC_127um and 1717SCC_140um | Rayence Co., Ltd. | MQB | Class II | 2017-06-09 |
| K171419 | 1717SGC_127um and 1717SGC_140um | Rayence Co., Ltd. | MQB | Class II | 2017-06-09 |
| K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | LLZ | Class II | 2017-06-08 |
| K171086 | Accuray Precision Treatment Planning System | Accuray Incorporated | IYE | Class II | 2017-06-08 |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Minxray, Inc. | IZL | Class II | 2017-06-07 |
| K170250 | SmartTarget | Smarttarget, Ltd. | LLZ | Class II | 2017-06-07 |
| K170751 | MRIdian Linac System with 138-leaf Collimator | Viewray, Incorporated | IYE | Class II | 2017-06-07 |
| K170144 | StentBoost Live | Philips Medical Stystems Nederland BV | OWB | Class II | 2017-06-07 |
| K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX | Toshibamedical Systems Corporation | LNH | Class II | 2017-06-07 |
| K162372 | QT Ultrasound Breast Scanner-1 | Qt Ultrasound, LLC | IYO | Class II | 2017-06-06 |
| K170374 | SonoBook Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | IYN | Class II | 2017-06-06 |
| K171013 | Revolution ACT | Ge Hangwei Medical Systems Co., Ltd. | JAK | Class II | 2017-06-05 |
| K170130 | Dynamic Coronary Roadmap | Philips Medical Systems Nederland B.V. | OWB | Class II | 2017-06-02 |
| K170490 | Celesteion, PCA-9000A/3 | Toshibamedical Systems Corporation | KPS | Class II | 2017-06-01 |
| K170741 | GTK Disposable Needle Guides | Geotek Medikal Ltd Sti | ITX | Class II | 2017-06-01 |
| K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | NZT | Class II | 2017-06-01 |
| K170203 | System, Applicator, Radionuclide, Remote Controlled | Kobold, LLC | JAQ | Class II | 2017-06-01 |
| K170904 | Biograph Horizon PET/CT | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2017-06-01 |
| K171053 | syngo Dynamics Version VA30 | Siemens Healthcare GmbH | LLZ | Class II | 2017-06-01 |
| K171314 | QLAB Advanced Quantification Software | Philips Health Care | LLZ | Class II | 2017-05-30 |
| K170521 | TRINITY/3D PROSTATE SUITE | Koelis | IYN | Class II | 2017-05-30 |
| K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | Toshibamedical Systems Corporation | IYN | Class II | 2017-05-30 |
| K163505 | ARIETTA PRECISION | Hitachi , Ltd. | IYN | Class II | 2017-05-30 |
| K162574 | AmCAD-US | Amcad Biomed Corporation | LLZ | Class II | 2017-05-30 |
| K170133 | FFR V2.5 | Philips Volcano | IYO | Class II | 2017-05-26 |
| K171229 | DELL UP3017 with QUBYX PerfectLum bundle | Qubyx Software Technologies, Inc. | PGY | Class II | 2017-05-26 |
| K163140 | SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System | Gemss Medical Systems Co., Ltd. | OWB | Class II | 2017-05-26 |
| K170944 | LCD Monitor (MD310C, MD310G, MD210G) | Benq Corporation | PGY | Class II | 2017-05-25 |
| K170172 | UNiD Spine Analyzer | Medicrea International | LLZ | Class II | 2017-05-24 |
| K171194 | AS-10, CXDI-401RF | Canon, Inc. | OWB | Class II | 2017-05-24 |
| K163071 | vascuCAP | Elucid Bioimaging, Inc. | LLZ | Class II | 2017-05-24 |
| K171348 | Pinpoint GT Needle Guide Kits | C.R. Bard, Inc. | ITX | Class II | 2017-05-22 |
| K163394 | Hybrid3D | Hermes Medical Solutions AB | KPS | Class II | 2017-05-22 |
| K170752 | OEC Elite | Oec Medical Systems, Inc. | OWB | Class II | 2017-05-19 |
| K170303 | E5 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | 2017-05-19 |
| K161807 | BEAMSCAN | Ptw-Freiburg Physikalisch Technische-Werksraetten | IYE | Class II | 2017-05-19 |
| K170078 | Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley | Medisono, LLC | IYN | Class II | 2017-05-17 |
| K161601 | Dynamika | Image Analysis Limited | LLZ | Class II | 2017-05-17 |
| K170195 | QuantX | Quantitative Insights, Inc. | LLZ | Class II | 2017-05-17 |
| K171138 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | MQB | Class II | 2017-05-17 |
| K170338 | A-View | Stroke2prevent B.V. | ITX | Class II | 2017-05-16 |
| K163502 | iSR'obot Biopsy Kit | Biobot Surgical Pte., Ltd. | ITX | Class II | 2017-05-16 |
| K171137 | EVS 2430W, EVS 2430GW | DRTECH Corporation | MQB | Class II | 2017-05-15 |
| K170023 | SPiN Thoracic Navigation System | Veran Medical Technologies, Inc. | JAK | Class II | 2017-05-15 |
| K171119 | GM85 | Samsung Electronics Co., Ltd. | IZL | Class II | 2017-05-12 |
| K163622 | Lung Vision | Bodyvision Medical , Ltd. | LLZ | Class II | 2017-05-11 |
| K170419 | SurgiCase Viewer | Materialise NV | LLZ | Class II | 2017-05-11 |
| K171085 | GMR40 | Neurologica Corporation, A Subsidiary OF | MQB | Class II | 2017-05-11 |
| K163250 | Longitudinal Brain Imaging (LoBI) application | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2017-05-11 |
| K171022 | Ablation Confirmation | Neuwave Medical, Inc. | JAK | Class II | 2017-05-09 |
| K170180 | Will3D | Hdx Will Corp. | LLZ | Class II | 2017-05-08 |
| K170789 | In Reach | Curvebeam, LLC | JAK | Class II | 2017-05-05 |
14,721 clearances in the Radiology panel. Data: openFDA.