Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 22
- Latest Decision
- 2018-10-23
Clearances · page 35 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182622 | GU60A, GU60A-65 | Samsung Electronics Co., Ltd. | KPR | Class II | 2018-10-23 |
| K172533 | GM Implant Tubes, Length Cutting Gauge | Varian Medical Systems, Inc. | JAQ | Class II | 2018-10-22 |
| K182561 | UroNav (Version 3.0) | Invivo Corporation | LLZ | Class II | 2018-10-19 |
| K182450 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2018-10-19 |
| K182282 | Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation | LNH | Class II | 2018-10-19 |
| K181433 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2018-10-19 |
| K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA | GE Healthcare | MOS | Class II | 2018-10-19 |
| K180516 | EchoS | Echolight S.P.A | MUA | Class II | 2018-10-19 |
| K182591 | RadiForce RX360, RX360-AR | Eizo Corporation | PGY | Class II | 2018-10-18 |
| K182348 | 14HK701G-W | Lg Electronics.Inc | MQB | Class II | 2018-10-18 |
| K182034 | Arterys MICA | Arterys, Inc. | LLZ | Class II | 2018-10-17 |
| K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2018-10-17 |
| K182546 | Alphenix, INFX-8000H/B, V8.0 | Canon Medical Systems Corporation | OWB | Class II | 2018-10-17 |
| K182550 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2018-10-17 |
| K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. | NQQ | Class II | 2018-10-16 |
| K182614 | RCT700 | Ray Co., Ltd. | OAS | Class II | 2018-10-16 |
| K182237 | uMI 550 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2018-10-12 |
| K182129 | MAGNETOM Sola | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2018-10-12 |
| K182504 | 3.0T Air MP M, 3.0T Air MP L | Ge Healthcare Coils (Usa Instruments, Inc.) | MOS | Class II | 2018-10-12 |
| K181460 | OnePacs System | Onepacs, LLC | LLZ | Class II | 2018-10-11 |
| K181617 | E-CUBE 8 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2018-10-11 |
| K181892 | Ziostation2 | Ziosoft, Inc. | LLZ | Class II | 2018-10-09 |
| K181322 | MAGNETOM Sola | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2018-10-05 |
| K182189 | Encompass SRS Headframe ; Encompass MR SRS Headframe | Qfix | IYE | Class II | 2018-10-04 |
| K182533 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation | MQB | Class II | 2018-10-04 |
| K173076 | CURA 16; ScintCare CT16 | Fmi Medical Systems, Inc. | JAK | Class II | 2018-10-04 |
| K181371 | uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2018-10-03 |
| K182050 | Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch | Siemens Medical Solutions USA, Inc. | IYE | Class II | 2018-10-03 |
| K182539 | 2MP Color LCD Monitor CL-R211 | Jvckenwood Corporation | PGY | Class II | 2018-10-03 |
| K181370 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2018-10-03 |
| K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device | Varian Medical Systems, Inc. | JAQ | Class II | 2018-10-03 |
| K182415 | Alphenix, INFX-8000F/B, V8.0 | Canon Medical Systems Corporation | OWB | Class II | 2018-09-28 |
| K182376 | Harmony | Topcon Medical Systems, Inc. | NFJ | Class II | 2018-09-28 |
| K181277 | E-CUBE 12 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2018-09-28 |
| K182290 | IBM iConnect Access | Merge Healthcare Incorporated | LLZ | Class II | 2018-09-25 |
| K181773 | Synapse 3D Optional Tools | Fujifilm Corporation | LLZ | Class II | 2018-09-25 |
| K182317 | AMADEO M-DR mini, AMADEO M-AX mini | Oehm Und Rehbein GmbH | IZL | Class II | 2018-09-24 |
| K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | Terarecon,Inc. | LLZ | Class II | 2018-09-24 |
| K182310 | Volpara Imaging Software | Volpara Health Technologies Limited | LLZ | Class II | 2018-09-21 |
| K172418 | OpenSight | Novarad Corporation | LLZ | Class II | 2018-09-21 |
| K181789 | VeriSuite | Medcom GmbH | LHN | Class II | 2018-09-21 |
| K181926 | InVivo Web Viewer | Anatomage, Inc. | LLZ | Class II | 2018-09-21 |
| K181783 | LOGIQ P9; LOGIQ P7 | GE Healthcare | IYN | Class II | 2018-09-20 |
| K182213 | QT Ultrasound Breast Scanner - 1 | Qt Ultrasound, LLC | IYO | Class II | 2018-09-14 |
| K182223 | Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A | Canon Medical Systems, USA | JAK | Class II | 2018-09-14 |
| K181874 | MX40 Mobile Digital X-ray System | Huestis Machine Corporation | IZL | Class II | 2018-09-14 |
| K173926 | DORADOnova MR3T | Lap GmbH Laser Applikationen | IYE | Class II | 2018-09-14 |
| K181576 | Planmeca Viso | Planmeca Oy | OAS | Class II | 2018-09-13 |
| K181415 | XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 | Canon Medical Systems Corporation | OWB | Class II | 2018-09-10 |
| K182230 | Multi Modality Viewer | Vital Images, Inc. | LLZ | Class II | 2018-09-07 |
| K182079 | Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask | Medtec Inc. Dba Civco Medical Solutions | IYE | Class II | 2018-09-07 |
| K170702 | mediCAD 4.0 | Medicad Hectec GmbH | LLZ | Class II | 2018-09-07 |
| K182147 | CTXX85 | Analogic Corporation | JAK | Class II | 2018-09-07 |
| K182208 | syngo.via View&GO (Version VA10A) | Siemens Healthcare GmbH | LLZ | Class II | 2018-09-07 |
| K181537 | GLOW800 | Leica Microsystems (Schweiz) AG | IZI | Class II | 2018-09-07 |
| K182234 | Optima XR240amx | Ge Medical Systems, LLC | IZL | Class II | 2018-09-06 |
| K182153 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | IYO | Class II | 2018-09-06 |
| K182138 | Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD | Eleckta Limited | IYE | Class II | 2018-09-05 |
| K180006 | AmCAD-UT Detection 2.2 | Amcad Biomed Corporation | LLZ | Class II | 2018-08-31 |
| K181185 | Change Healthcare Enterprise Viewer | Change Healthcare Canada Company | LLZ | Class II | 2018-08-29 |
| K181313 | BenQ Diagnostic Ultrasound System | Qisda Corporation | IYN | Class II | 2018-08-27 |
| K181609 | RadiForce GX560, GX560-AR | Eizo Corporation | PGY | Class II | 2018-08-24 |
| K180974 | CBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2018-08-17 |
| K181767 | Cios Select | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2018-08-17 |
| K181966 | SmartPerfusion | Philips Medical Systems Nederlands B.V. | OWB | Class II | 2018-08-17 |
| K181983 | PreXion 3D Excelsior | Prexion Corporation | OAS | Class II | 2018-08-17 |
| K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | Genoray Co., Ltd. | OWB | Class II | 2018-08-17 |
| K180077 | NeuroQ 3.8 | Syntermed | KPS | Class II | 2018-08-16 |
| K180522 | IGTFusion | Igi Technologies | LLZ | Class II | 2018-08-16 |
| K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works | LHN | Class II | 2018-08-15 |
| K181407 | Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. | OWB | Class II | 2018-08-15 |
| K181414 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2018-08-14 |
| K181318 | ONIS-PACS | Digitalcore Co., Ltd. | LLZ | Class II | 2018-08-13 |
| K181593 | Vantage Galan 3T, MRT-3020/A7, V5.0 | Canon Medical Systems Corporation | LNH | Class II | 2018-08-13 |
| K173848 | Model WP-3840 and WP-3040 | Cnmc Co., Inc. | IYE | Class II | 2018-08-07 |
| K181218 | AlignRT Plus | Vision Rt, Ltd. | IYE | Class II | 2018-08-07 |
| K181962 | CubeVue | Curvebeam, LLC | LLZ | Class II | 2018-08-07 |
| K171435 | VirtuOst Vertebral Fracture Assessment | O.N. Diagnostics, LLC | LLZ | Class II | 2018-08-03 |
| K181797 | Philips CT Big Bore Sliding Gantry Configuration | Phillips Medical Systems (Cleveland), Inc. | JAK | Class II | 2018-08-03 |
| K181479 | Ingenia Ambition S and Ingenia Ambition X | Philips Medical Systems Nederland B.V. | LNH | Class II | 2018-08-03 |
| K181830 | Azurion R2.0 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2018-08-02 |
| K171977 | miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer | Hinacom Software and Technology, Ltd. | LLZ | Class II | 2018-08-02 |
| K181804 | Alphenix, INFX-8000C/B, V8.0 | Canon Medical Systems Corporation | OWB | Class II | 2018-08-02 |
| K181432 | ProVectra 3D Prime with VistaSoft | Durr Dental SE | OAS | Class II | 2018-08-02 |
| K180737 | Ultrasound Scanner System bk2300 | Bk Medical Aps | IYN | Class II | 2018-08-01 |
| K180647 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2018-08-01 |
| K180912 | TE7/TE5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2018-07-30 |
| K181452 | RCT800 | Ray Co., Ltd. | OAS | Class II | 2018-07-27 |
| K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | IYN | Class II | 2018-07-27 |
| K181670 | Alphenix, INFX-8000V/B, V8.0 | Canon Medical Systems Corporation | OWB | Class II | 2018-07-25 |
| K173444 | Quantitative Total Extensible Imaging (QTxI) | Aiq Solutions, Inc. | LLZ | Class II | 2018-07-23 |
| K181626 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | IZL | Class II | 2018-07-20 |
| K181629 | GC85A | Samsung Electronics Co., Ltd. | KPR | Class II | 2018-07-20 |
| K181631 | GR40CW | Samsung Electronics Co., Ltd. | MQB | Class II | 2018-07-20 |
| K180629 | DentiqGuide | 3D Industrial Imaging Co., Ltd. | LLZ | Class II | 2018-07-19 |
| K181834 | Ultimax-i, DREX-UI80 (V1.60) | Canon Medical Systems Corporation | OWB | Class II | 2018-07-19 |
| K181345 | Image Filing Software NAVIS-EX | Nidek Co., Ltd. | NFJ | Class II | 2018-07-19 |
| K180027 | ACCUSYTE 3D Fiducial Marker | Radiation Products, LLC | IYE | Class II | 2018-07-18 |
| K181376 | ARIETTA 65 | Hitachi Healthcare Americas Corporation | IYN | Class II | 2018-07-18 |
| K171272 | Cook-Swartz Doppler Flow Probe | Cook Incorporated | ITX | Class II | 2018-07-17 |
14,721 clearances in the Radiology panel. Data: openFDA.