Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 23
- Latest Decision
- 2021-08-17
Clearances · page 24 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K201573 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | LLZ | Class II | 2021-08-17 |
| K212230 | TruSPECT Radiological Image Processing Station | Spectrum Dynamics Medical, Ltd. | LLZ | Class II | 2021-08-16 |
| K211969 | EMM Ultrasonic Transducer Cover | Exact Medical Manufacturing | ITX | Class II | 2021-08-13 |
| K211383 | NFLK-2501 Portable X-ray Unit | Neuf, Inc. | IZL | Class II | 2021-08-13 |
| K211777 | ARCO FP-S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | OWB | Class II | 2021-08-13 |
| K211179 | InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. | QAS | Class II | 2021-08-12 |
| K211863 | eVolve PACS | Evolve Pacs, Inc. | LLZ | Class II | 2021-08-12 |
| K210912 | Excelsius3D | Globus Medical, Inc. | OWB | Class II | 2021-08-12 |
| K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | 2021-08-11 |
| K210820 | EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontológica | OAS | Class II | 2021-08-10 |
| K211299 | X-CUBE 70 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2021-08-09 |
| K211300 | X-CUBE 90 | Alpinion Medical Systems Co., Ltd. | IYN | Class II | 2021-08-09 |
| K211764 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | KPS | Class II | 2021-08-06 |
| K212100 | Kosmos | EchoNous, Inc. | IYN | Class II | 2021-08-06 |
| K211725 | Senographe Pristina | GE Healthcare | MUE | Class II | 2021-08-06 |
| K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2021-08-04 |
| K212144 | Remex KA6 | Remedi Co., Ltd. | IZL | Class II | 2021-08-03 |
| K212175 | DynaCAD | Invivo Corporation | LLZ | Class II | 2021-08-02 |
| K211431 | breastscape v1.0 | Olea Medical | QIH | Class II | 2021-08-02 |
| K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | 2021-07-30 |
| K212035 | FibroScan 230 | Echosens | IYO | Class II | 2021-07-30 |
| K210154 | Labat series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | IYN | Class II | 2021-07-30 |
| K211222 | qER-Quant | Qure.Ai Technologies | QIH | Class II | 2021-07-30 |
| K211790 | DX-D Imaging Package with XD Detectors | Agfa N.V. | MQB | Class II | 2021-07-30 |
| K211663 | Zap-X Radiosurgical System | Zap Surgical Systems, Inc. | IYE | Class II | 2021-07-29 |
| K211655 | aPROMISE | Exini Diagnostics AB | LLZ | Class II | 2021-07-27 |
| K210469 | Insight Agile DRF | Imaging Engineering, LLC | JAA | Class II | 2021-07-27 |
| K212074 | ClariCT.AI | Claripi, Inc. | LLZ | Class II | 2021-07-27 |
| K211247 | PET VCAR | GE Medical Systems SCS | KPS | Class II | 2021-07-27 |
| K211279 | Volpara Imaging Software | Volpara Health Technologies Limited | LLZ | Class II | 2021-07-27 |
| K210791 | Us2.v1 | Eko.Ai Pte Ltd. D/B/A Us2.Ai | QIH | Class II | 2021-07-27 |
| K210468 | SC1 Handheld Ultrasound Imaging System (Model: SC1) | Fcu Co., Ltd. | IYO | Class II | 2021-07-23 |
| K211386 | MySpine WebPlanner & MyBalance | Medacta International S.A. | LLZ | Class II | 2021-07-23 |
| K210415 | QSM software, QSMetric | Medimagemetric, LLC | LNH | Class II | 2021-07-22 |
| K211633 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2021-07-22 |
| K203411 | syngo.CT Skull Unfolding | Siemens Medical Solutions USA, Inc. | JAK | Class II | 2021-07-22 |
| K211939 | ExacTrac Dynamic | Brainlab AG | IYE | Class II | 2021-07-22 |
| K210666 | Chest-CAD | Imagen Technologies, Inc. | MYN | Class II | 2021-07-20 |
| K210719 | Change Healthcare Anatomical AI | Change Healthcare Canada Company | QIH | Class II | 2021-07-20 |
| K203765 | ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray | Zirkonzahn Srl | LLZ | Class II | 2021-07-20 |
| K211859 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2021-07-20 |
| K203509 | SMART FINDER | Ims Giotto S.P.A. | IZH | Class II | 2021-07-14 |
| K211506 | PowerLook Density Assessment V4.0 | Icad, Inc. | QIH | Class II | 2021-07-12 |
| K211491 | RadiForce RX370 | Eizo Corporation | PGY | Class II | 2021-07-12 |
| K211542 | PRIMO S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | MQB | Class II | 2021-07-09 |
| K210713 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2021-07-09 |
| K203659 | iSR'obot Mona Lisa 1.0 | Biobot Surgical Pte., Ltd. | IYO | Class II | 2021-07-08 |
| K201835 | PRE-SURE | Lazarus 3D, Inc. | LLZ | Class II | 2021-07-08 |
| K211480 | NubeX | Techheim Co., Ltd. | LLZ | Class II | 2021-07-08 |
| K211788 | HALO | Nicolab B.V. | QAS | Class II | 2021-07-08 |
| K211818 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. | LNH | Class II | 2021-07-07 |
| K210653 | ONE Planner Hip | Orthosoft D/B/A Zimmer Cas | LLZ | Class II | 2021-07-07 |
| K211511 | decimal Bolus | .Decimal, LLC | MUJ | Class II | 2021-07-01 |
| K211782 | ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 | Controlrad, Inc. | OWB | Class II | 2021-07-01 |
| K211337 | 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 | 2021-07-01 |
| K210611 | MAGNETOM Free.Max | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2021-07-01 |
| K203645 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 | Supersonic Imagine | IYN | Class II | 2021-06-29 |
| K203733 | 12MP Color Digital Mammography LCD Monitor CL-S1200 | Jvckenwood Corporation | PGY | Class II | 2021-06-29 |
| K210843 | STAGE | Spintech, Inc. | LNH | Class II | 2021-06-29 |
| K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | MUJ | Class II | 2021-06-29 |
| K211656 | 3D Echo v1.1 | Jointvue, LLC | LLZ | Class II | 2021-06-25 |
| K211232 | Apache Ultrasound System | Aco Healthcare Co., Ltd. | IYN | Class II | 2021-06-25 |
| K203657 | Vu-Path Ultrasound System | Crystalline Medical | IYN | Class II | 2021-06-25 |
| K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | IYO | Class II | 2021-06-25 |
| K211623 | THD Procto Software System | Thd Spa | IYO | Class II | 2021-06-24 |
| K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | OWB | Class II | 2021-06-24 |
| K210959 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2021-06-24 |
| K203720 | MICROMATE | Isys Medizintechnik GmbH | JAK | Class II | 2021-06-22 |
| K211215 | SenoBright HD | GE Healthcare | MUE | Class II | 2021-06-22 |
| K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | MUE | Class II | 2021-06-21 |
| K203514 | Precise Position | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | 2021-06-17 |
| K202718 | Qmenta Care Platform Family | Mint Labs, Inc., D/B/A. Qmenta | LLZ | Class II | 2021-06-16 |
| K203244 | CellChek 20 rc | Konan Medical, Inc. | NFJ | Class II | 2021-06-15 |
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | Elekta Limited | IYE | Class II | 2021-06-11 |
| K210416 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2021-06-10 |
| K210699 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | Class II | 2021-06-10 |
| K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2021-06-10 |
| K211590 | Fiducial Marker | Carbon Medical Technologies, Inc. | IYE | Class II | 2021-06-10 |
| K211216 | Vivid S60N / Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2021-06-09 |
| K210591 | Palm Bladder Scanner - PBSV7.1 | Mianyang Meike Electronic Equipment Co., Ltd. | IYO | Class II | 2021-06-09 |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | ABBOTT MEDICAL | NQQ | Class II | 2021-06-08 |
| K211108 | Prudent 1717, Prudent 1417, Prudent 1212 | Pixxgen Corporation | MQB | Class II | 2021-06-04 |
| K211473 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | IZL | Class II | 2021-06-04 |
| K210404 | Transpara 1.7.0 | Screenpoint Medical B.V. | QDQ | Class II | 2021-06-02 |
| K200704 | ZedView | Lexi Co., Ltd. | LLZ | Class II | 2021-05-27 |
| K211098 | Breast Volume Navigator (BVN) Model G-2000 | Metritrack, Inc. | IYO | Class II | 2021-05-26 |
| K211312 | Universal Viewer | GE Healthcare | LLZ | Class II | 2021-05-21 |
| K211423 | Rover | Micro-X Limited | IZL | Class II | 2021-05-21 |
| K211001 | C-Qual M Breastboard; Monarch Overhead Arm Positioner | Medtec, Inc. Dba Civco Medical Solutions and Civco | IYE | Class II | 2021-05-20 |
| K210257 | Xoran Workstation, Model 10050 | Xoran Technologies, LLC | LLZ | Class II | 2021-05-20 |
| K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | KPS | Class II | 2021-05-19 |
| K210187 | Overjet Dental Assist | Overjet, Inc. | LLZ | Class II | 2021-05-19 |
| K210237 | CINA CHEST | Avicenna.Ai | QAS | Class II | 2021-05-19 |
| K211037 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | 2021-05-17 |
| K202793 | Cercare Medical Neurosuite | Cercare Medical Aps | LLZ | Class II | 2021-05-17 |
| K202747 | Klarity Bolus | Klarity Medical & Equipment (GZ) Co., Ltd. | IYE | Class II | 2021-05-14 |
| K210072 | HOLOSCOPE-i | Real View Imaging , Ltd. | LLZ | Class II | 2021-05-14 |
| K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2021-05-13 |
| K211118 | SIGNA 7.0T | Ge Medical Systems, LLC | LNH | Class II | 2021-05-13 |
| K210557 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2021-05-12 |
14,721 clearances in the Radiology panel. Data: openFDA.