Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 24
- Latest Decision
- 2019-01-15
Clearances · page 34 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K183497 | JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2019-01-15 |
| K182517 | MULTIX Impact | Siemens Medi Cal Solutions, Inc. | KPR | Class II | 2019-01-11 |
| K183137 | uMR 580, uMR 588 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2019-01-11 |
| K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | MQB | Class II | 2019-01-11 |
| K182636 | DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2019-01-10 |
| K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | MWP | Class II | 2019-01-10 |
| K183422 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2019-01-09 |
| K183713 | Wireless Digital Flat Detector | Iray Technology Taicang , Ltd. | MQB | Class II | 2019-01-09 |
| K181637 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2019-01-09 |
| K183133 | MRCP+ v1.0 | Perspectum Diagnostics, Ltd. | LLZ | Class II | 2019-01-09 |
| K182632 | HS30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-01-08 |
| K183143 | uCT 520, uCT 528 | Shangai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2019-01-03 |
| K182855 | ProKnow DS | Proknow, LLC | LLZ | Class II | 2019-01-02 |
| K183101 | Zenition 50 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2018-12-31 |
| K180867 | AmCAD-UO | Amcad Biomed Corporation | LLZ | Class II | 2018-12-28 |
| K182130 | iSchemaView RAPID | Ischemaview, Inc. | LLZ | Class II | 2018-12-27 |
| K182845 | minisono | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2018-12-27 |
| K182564 | Quantib ND | Quantib B.V. | LLZ | Class II | 2018-12-27 |
| K182750 | 4D View | GE Medical Systems Ultrasound and Primary Care Diagnostics | LLZ | Class II | 2018-12-21 |
| K183012 | vascuCAP | Elucid Bioimaging, Inc. | LLZ | Class II | 2018-12-21 |
| K182165 | Color Doppler Ultrasound System; Model: mEye1 and mEye2 | Shenzhen Well.D Medical Electronics Co., Ltd. | IYN | Class II | 2018-12-20 |
| K173041 | 3DIEMME RealGUIDE | 3Diemme , Ltd. | LLZ | Class II | 2018-12-20 |
| K182938 | Emission Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2018-12-18 |
| K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | LLZ | Class II | 2018-12-18 |
| K182595 | HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2018-12-18 |
| K182688 | SKR 3000 | Konica Minolta, Inc. | MQB | Class II | 2018-12-18 |
| K182419 | Centricity Universal Viewer | GE Healthcare | LLZ | Class II | 2018-12-14 |
| K182601 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | LLZ | Class II | 2018-12-14 |
| K182805 | RCT800 | Ray Co., Ltd. | OAS | Class II | 2018-12-14 |
| K182207 | TR90BH | Minxray, Inc. | IZL | Class II | 2018-12-14 |
| K182359 | HipCheck | Stryker Corp. | LLZ | Class II | 2018-12-13 |
| K181498 | X-ray Imaging System for the McLaren Proton Treatment System | Ehmetdx, LLC | LHN | Class II | 2018-12-10 |
| K183111 | Contour 24 | Quality Electrodynamics, LLC | MOS | Class II | 2018-12-07 |
| K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | Samsung Electronics Co., Ltd. | KPR | Class II | 2018-12-07 |
| K183212 | Nexus DR Digital X-ray Imaging System with stitching | Varex Imaging Corporation | MQB | Class II | 2018-12-07 |
| K183286 | 17HK701G-W | Lg Electronics.Inc | MQB | Class II | 2018-12-07 |
| K182016 | Simplicit90Y | Mirada Medical, Ltd. | LLZ | Class II | 2018-12-06 |
| K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2018-12-06 |
| K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2018-12-06 |
| K182926 | IntelliSpace Radiology | Philips Healthcare Informatics, Inc. | LLZ | Class II | 2018-12-06 |
| K182373 | PowerLook Tomo Detection V2 Software | Icad, Inc. | QDQ | Class II | 2018-12-06 |
| K173749 | AMRA Profiler | Amra Medical AB | LNH | Class II | 2018-12-06 |
| K183191 | 6420 Ultrasound System | Esaote, S.p.A. | IYN | Class II | 2018-12-04 |
| K181825 | CAAS MR Solutions | Pie Medical Imaging BV | LLZ | Class II | 2018-12-04 |
| K182076 | Elekta Unity | Elekta Limited | IYE | Class II | 2018-12-04 |
| K183037 | Monaco RTP System | Elekta, Inc. | MUJ | Class II | 2018-12-04 |
| K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | IYE | Class II | 2018-12-04 |
| K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2018-12-04 |
| K173083 | IMPLANTER DENTAL PLANNING SOFTWARE | Implanter, LLC | LLZ | Class II | 2018-12-03 |
| K182218 | FerriSmart Analysis System | Resonance Health Analysis Services Pty, Ltd. | PCS | Class II | 2018-11-30 |
| K182815 | XVWeb 3D | Apteryx, Inc. | LLZ | Class II | 2018-11-30 |
| K180918 | Planmed Verity | Planmed OY | OAS | Class II | 2018-11-30 |
| K182336 | SubtlePET | Subtle Medical, Inc. | KPS | Class II | 2018-11-30 |
| K183038 | Corin Optimized Positioning System (OPS) Plan | Corin USA | LLZ | Class II | 2018-11-26 |
| K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | LLZ | Class II | 2018-11-26 |
| K182431 | Konicaminolta DI-X1 | Konica Minolta, Inc. | LLZ | Class II | 2018-11-26 |
| K182134 | ARiX RAD Radiographic System | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | KPR | Class II | 2018-11-26 |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System | Accuray Incorporated | IYE | Class II | 2018-11-23 |
| K173744 | ProFuse CAD | Eigen | LLZ | Class II | 2018-11-21 |
| K182277 | Versana Premier | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2018-11-21 |
| K181704 | Transpara | Screenpoint Medical B.V. | QDQ | Class II | 2018-11-21 |
| K181247 | Vitrea CT Brain Perfusion | Vital Images, Inc. | LLZ | Class II | 2018-11-20 |
| K182715 | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | IYN | Class II | 2018-11-20 |
| K182291 | 6MP Color LCD Monitor (C61W+) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | 2018-11-20 |
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | Rapid Biomedical GmbH | MOS | Class II | 2018-11-16 |
| K182626 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | OXO | Class II | 2018-11-16 |
| K182958 | 1.5T 16ch Breast Coil | Neocoil, LLC | MOS | Class II | 2018-11-16 |
| K181646 | Celesteion, PCA-9000A/3, V6.5 | Canon Medical Systems Corporation | JAK | Class II | 2018-11-16 |
| K181985 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | IYN | Class II | 2018-11-15 |
| K182603 | Z6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2018-11-14 |
| K180478 | RectalPro 75 Endorectal Balloon | Qlrad International , Ltd. | PCT | Class II | 2018-11-13 |
| K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | KPS | Class II | 2018-11-09 |
| K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | IYN | Class II | 2018-11-09 |
| K172999 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2018-11-07 |
| K173001 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2018-11-07 |
| K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2018-11-06 |
| K181939 | icobrain | Icometrix NV | LLZ | Class II | 2018-11-06 |
| K181934 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | IYN | Class II | 2018-11-06 |
| K181501 | Afina | Neurovision Imaging, LLC | NFJ | Class II | 2018-11-02 |
| K182596 | Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | 2018-11-02 |
| K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) | Villa Sistemi Medicali S.P.A. | OAS | Class II | 2018-11-02 |
| K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | GE Healthcare | OWB | Class II | 2018-11-02 |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. | NQQ | Class II | 2018-11-02 |
| K182427 | Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | 2018-11-02 |
| K171199 | AVIEW | Coreline Soft Co., Ltd. | LLZ | Class II | 2018-10-31 |
| K182679 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 | Canon Medical Systems Corporation | IYN | Class II | 2018-10-31 |
| K182880 | Halifax Imaging Kit | Halifax Biomedical, Inc. | KPR | Class II | 2018-10-31 |
| K181550 | Cios Spin | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2018-10-30 |
| K182177 | Accipiolx | Maxq-Al , Ltd. | QAS | Class II | 2018-10-26 |
| K182299 | MAGNETOM Aera | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2018-10-26 |
| K173965 | Implant Planning Software | Inteware Co., Ltd. | LLZ | Class II | 2018-10-26 |
| K182464 | PeekMed | Peek Health, S.A. | LLZ | Class II | 2018-10-25 |
| K181468 | Hybrid3D | Hermes Medical Solutions AB | KPS | Class II | 2018-10-25 |
| K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2018-10-25 |
| K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | OWB | Class II | 2018-10-24 |
| K182647 | GC70 | Samsung Electronics Co., Ltd. | KPR | Class II | 2018-10-24 |
| K182318 | Retina Workplace | Carl Zeiss Meditec, Inc. | NFJ | Class II | 2018-10-24 |
| K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech | C. R. Bard | IYO | Class II | 2018-10-24 |
| K182529 | Xperius Ultrasound System | Philips Ultrasound, Inc. | IYN | Class II | 2018-10-23 |
| K181964 | JiveX | Visus Health IT GmbH | LLZ | Class II | 2018-10-23 |
14,721 clearances in the Radiology panel. Data: openFDA.