Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 28
- Latest Decision
- 2019-08-07
Clearances · page 32 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K191394 | ILLUMISITE Platform | Covidien, LLC | JAK | Class II | 2019-08-07 |
| K183458 | exoplan 2.3 | Exocad GmbH | LLZ | Class II | 2019-08-06 |
| K191158 | The AIO Solution | Orfit Industries NV | IYE | Class II | 2019-08-06 |
| K191262 | aBSI | Exini Diagnostics AB | LLZ | Class II | 2019-08-05 |
| K191877 | FLUOROspeed | Shimadzu Corporation | JAA | Class II | 2019-08-05 |
| K191813 | MobileDiagnost wDR 2.2 | Sedecal., Sa. | IZL | Class II | 2019-08-02 |
| K191267 | ImagingRing System on Rails | Medphoton GmbH | IYE | Class II | 2019-08-01 |
| K183193 | MREplus+ Software | Resoundant, Inc. | LLZ | Class II | 2019-08-01 |
| K191761 | Mobius3D | Varian Medical Systems, Inc. | IYE | Class II | 2019-07-31 |
| K191797 | BiomarC Fiducial Marker | Carbon Medical Technologies | IYE | Class II | 2019-07-29 |
| K190809 | Sample Imaging for Senographe Pristina | GE Healthcare | MUE | Class II | 2019-07-29 |
| K191136 | Access CT | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | 2019-07-29 |
| K183271 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-07-26 |
| K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | Ge Medical Systems, LLC | JAK | Class II | 2019-07-26 |
| K191699 | Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co. , Ltd. | KPR | Class II | 2019-07-24 |
| K191662 | Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation | LNH | Class II | 2019-07-23 |
| K182971 | SpaceOAR Vue Hydrogel | Augmenix, Inc. | OVB | Class II | 2019-07-19 |
| K191309 | syngo.via MI Workflows VB40A, Scenium | Siemens Medical Soultions USA, Inc. | LLZ | Class II | 2019-07-19 |
| K191117 | NvisionVLE Low-profile Optical Probe | Ninepoint Medical, Inc. | NQQ | Class II | 2019-07-19 |
| K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | IYN | Class II | 2019-07-19 |
| K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | NFJ | Class II | 2019-07-18 |
| K191616 | Orthophos S | Dentsply Sirona | OAS | Class II | 2019-07-16 |
| K190457 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | KPS | Class II | 2019-07-12 |
| K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | LLZ | Class II | 2019-07-12 |
| K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2019-07-12 |
| K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | LLZ | Class II | 2019-07-11 |
| K183041 | Full Digital Colour Doppler Ultrasonic Diagnostic System | Wuhan Zoncare Bio-medical Electronics Co., Ltd. | IYN | Class II | 2019-07-10 |
| K191541 | Vave Personal Ultrasound System | Vave Health, Inc. | IYO | Class II | 2019-07-10 |
| K190137 | Identify | Varian Medical Systems, Inc. | IYE | Class II | 2019-07-10 |
| K182875 | DeepCT | Deep01 Limited | QAS | Class II | 2019-07-10 |
| K190064 | nView system 1 | Nview Medical, Inc. | OWB | Class II | 2019-07-08 |
| K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | JAQ | Class II | 2019-07-08 |
| K191384 | RayCare 2.3 | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2019-07-08 |
| K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE | Canon Medical Systems Corporation | JAK | Class II | 2019-07-05 |
| K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2019-07-05 |
| K191495 | Biopsy Positioner | Fujifilm Corporation | IZH | Class II | 2019-07-03 |
| K191468 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-07-03 |
| K190442 | Koios DS for Breast | Koios Medical, Inc. | POK | Class II | 2019-07-03 |
| K191451 | CMDR 2CW (Multiple models) | Minxray, Inc. | IZL | Class II | 2019-07-03 |
| K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 | Jvckenwood Corporation | PGY | Class II | 2019-07-02 |
| K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | LNH | Class II | 2019-07-01 |
| K183173 | LIGHTMED Ultrasound System | Lightmed USA, Inc. | IYO | Class II | 2019-07-01 |
| K182683 | Z-Robot Patient Positioning System | Chinan Biomedical Technology, Inc. | JAI | Class II | 2019-06-27 |
| K190017 | LiverMultiScan (LMSv3) | Perspectum Diagnostics, Ltd. | LNH | Class II | 2019-06-27 |
| K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2019-06-27 |
| K191128 | Vantage Titan 3T, MRT-3010, V2.5 | Canon Medical Systems Corporation | LNH | Class II | 2019-06-26 |
| K190096 | R2GATE | Megagen Implant Co., Ltd. | LLZ | Class II | 2019-06-26 |
| K183170 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | 2019-06-24 |
| K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | OXO | Class II | 2019-06-21 |
| K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | MWP | Class II | 2019-06-20 |
| K191418 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2019-06-19 |
| K190387 | RayStation | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2019-06-19 |
| K190913 | QLAB Advanced Quantification Software 13 | Philips Health Care | LLZ | Class II | 2019-06-18 |
| K183460 | ClariCT.AI | Claripi, Inc. | LLZ | Class II | 2019-06-13 |
| K190424 | HealthICH | Zebra Medical Vision, Ltd. | QAS | Class II | 2019-06-13 |
| K190228 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | IYN | Class II | 2019-06-13 |
| K191036 | SyMRI | Syntheticmr AB | LNH | Class II | 2019-06-13 |
| K191055 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-06-12 |
| K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE | Canon Medical Systems Corporation | JAK | Class II | 2019-06-12 |
| K191115 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-06-12 |
| K191310 | Insight Essentials DRF Digital Imaging System | Imaging Engineering, LLC | JAA | Class II | 2019-06-10 |
| K191072 | 7410 Ultrasound System (MyLabSigma) | Esaote, S.p.A. | IYN | Class II | 2019-06-10 |
| K190505 | Low Dose Lung Screening Option | Canon Medical Systems Corporation | JAK | Class II | 2019-06-05 |
| K191307 | Palm Bladder Scanner - PBSV5.1 | Mianyang Meike Electronic Equipment Co., Ltd. | IYO | Class II | 2019-06-05 |
| K190874 | Materialise Mimics Enlight | Materialise NV | LLZ | Class II | 2019-06-05 |
| K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | 2019-06-04 |
| K190757 | MAGNETOM Avanto Fit | Siemens Medical Solution USA, Inc. | LNH | Class II | 2019-05-31 |
| K190896 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2019-05-31 |
| K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | QHA | Class II | 2019-05-30 |
| K191188 | ASHK100G | Lg Electronics | LLZ | Class II | 2019-05-30 |
| K182716 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | JAK | Class II | 2019-05-29 |
| K191157 | uMR 780, uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2019-05-29 |
| K190802 | Envision ultrasound pad and cover | Civco Medical Solutions | ITX | Class II | 2019-05-24 |
| K190444 | HERA I10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2019-05-22 |
| K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W) | Suzhou Lischka Medtech Co., Ltd. | IYO | Class II | 2019-05-22 |
| K182374 | LIAC S | Sit Sordina Iort Technologies Spa | IYE | Class II | 2019-05-22 |
| K191025 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | IZL | Class II | 2019-05-17 |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix , Ltd. | IYN | Class II | 2019-05-16 |
| K191040 | syngo.via (Version VB40A) | Siemens Healthcare GmbH | LLZ | Class II | 2019-05-16 |
| K183292 | Topaz Mobile DR System | DRGEM Corporation | IZL | Class II | 2019-05-15 |
| K190848 | JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | PGY | Class II | 2019-05-14 |
| K190764 | SurgicalAR | Medivis, Inc. | LLZ | Class II | 2019-05-13 |
| K183109 | ControlRad Trace Model 8 | Controlrad, Inc. | OWB | Class II | 2019-05-13 |
| K190995 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | IYN | Class II | 2019-05-10 |
| K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | Esaote, S.p.A. | IYN | Class II | 2019-05-10 |
| K182460 | MD-6000P Bladder Scanner | MEDA Co., Ltd. | IYO | Class II | 2019-05-06 |
| K190900 | Biograph Vision | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2019-05-06 |
| K190362 | HealthPNX | Zebra Medical Vision, Ltd. | QFM | Class II | 2019-05-06 |
| K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | MUJ | Class II | 2019-04-30 |
| K190894 | TOTIM Patient Cushion Immobilization System | Essebi Medical Srl | IYE | Class II | 2019-04-30 |
| K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Rayence Co., Ltd. | LLZ | Class II | 2019-04-30 |
| K183248 | Synapse Enterprise Viewer Version 1.0 | Fujifilm Corporation | LLZ | Class II | 2019-04-25 |
| K190042 | Brainlab Elements Image Fusion Angio | Brainlab AG | LLZ | Class II | 2019-04-25 |
| K190601 | MasteRad MX30 | Medicatech USA | KPR | Class II | 2019-04-25 |
| K190812 | RAYSCAN a-Expert3D | Ray Co., Ltd. | OAS | Class II | 2019-04-24 |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | OAS | Class II | 2019-04-24 |
| K190791 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | LLZ | Class II | 2019-04-19 |
| K183593 | Lung Vision System | Bodyvision Medical , Ltd. | LLZ | Class II | 2019-04-18 |
| K183332 | BRAXX Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. | JAQ | Class II | 2019-04-16 |
| K190072 | BriefCase | Aidoc Medical , Ltd. | QAS | Class II | 2019-04-15 |
14,721 clearances in the Radiology panel. Data: openFDA.