Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 37
- Latest Decision
- 2026-07-24
Clearances · page 2 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K262383 | LumenCare Azure | Nucletron B.V. | JAQ | Class II | 2026-07-24 |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | Philips Medical Systems Nederland B.V. | MOS | Class II | 2026-07-24 |
| K260192 | DIANA | ROPCA ApS | QIH | Class II | 2026-07-24 |
| K262462 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | LLZ | Class II | 2026-07-24 |
| K261349 | SwiftMR | Airs Medical, Inc. | QIH | Class II | 2026-07-24 |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | ITX | Class II | 2026-07-24 |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | LLZ | Class II | 2026-07-23 |
| K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology, Inc. | OAS | Class II | 2026-07-23 |
| K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | QIH | Class II | 2026-07-23 |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system | Esonic Technology (Wuhan) Co., Ltd. | IYN | Class II | 2026-07-23 |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | Beijing Konted Medical Technology Co.,Ltd | IYN | Class II | 2026-07-23 |
| K260500 | ResolutionMD | ResolutionMD, Inc. | LLZ | Class II | 2026-07-21 |
| K253770 | CardIQ Suite | GE Medical Systems SCS | JAK | Class II | 2026-07-21 |
| K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | QIH | Class II | 2026-07-20 |
| K260694 | ZEISS CLINIC 360 | Carl Zeiss Meditec, AG | NFJ | Class II | 2026-07-17 |
| K253963 | Cubresa BrainPET | Cubresa, Inc. | OUO | Class II | 2026-07-17 |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | MYN | Class II | 2026-07-15 |
| K260338 | ThinkSono Guidance | ThinkSono GmbH | QJU | Class II | 2026-07-15 |
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | QIH | Class II | 2026-07-15 |
| K261085 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | QAS | Class II | 2026-07-13 |
| K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | OWB | Class II | 2026-07-10 |
| K261306 | AI Contouring (VA10A) | Varian Medical Systems | QKB | Class II | 2026-07-10 |
| K262120 | Avara Viewer | Avara Software | LLZ | Class II | 2026-07-10 |
| K253899 | 3D-Anywhere | Provect.AI | LLZ | Class II | 2026-07-09 |
| K253751 | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | QFM | Class II | 2026-07-08 |
| K260750 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | MUJ | Class II | 2026-07-08 |
| K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | QIH | Class II | 2026-07-07 |
| K253942 | Pulmonex II Xenon System (132-503) | Mirion Technologies (Capintec), Inc. | IYT | Class II | 2026-07-07 |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | LLZ | Class II | 2026-07-06 |
| K260528 | OncoStudio | Oncosoft. Inc., | QKB | Class II | 2026-07-02 |
| K253884 | Koios DS (3.8) | Koios Medical, Inc. | POK | Class II | 2026-07-02 |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | LLZ | Class II | 2026-06-30 |
| K260667 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2026-06-29 |
| K253969 | ADAS 3D | Adas3D Medical S.L. | QIH | Class II | 2026-06-29 |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | QIH | Class II | 2026-06-29 |
| K260714 | MammoScreen® (5) | Therapixel | QDQ | Class II | 2026-06-26 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | LLZ | Class II | 2026-06-25 |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2026-06-25 |
| K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | JAK | Class II | 2026-06-24 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | LLZ | Class II | 2026-06-22 |
| K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | QIH | Class II | 2026-06-22 |
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | MQB | Class II | 2026-06-18 |
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | QIH | Class II | 2026-06-18 |
| K253050 | RadOncAI | Informai | MUJ | Class II | 2026-06-18 |
| K253058 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | IZL | Class II | 2026-06-18 |
| K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | MUE | Class II | 2026-06-18 |
| K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | QAS | Class II | 2026-06-18 |
| K260190 | ARTHUR | ROPCA ApS | IYO | Class II | 2026-06-18 |
| K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd. | MUI | Class II | 2026-06-17 |
| K253264 | myAblation Guide (VC10A) | Siemens Healthcare GmbH | QTZ | Class II | 2026-06-16 |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | 2026-06-16 |
| K260482 | DRE Duo | Jpi Healthcare Co, Ltd. | KPR | Class II | 2026-06-15 |
| K253690 | LungMaps | Siemens Healthineers AG | QIH | Class II | 2026-06-15 |
| K260300 | WatchMate Software | Anumana, Inc. | QIH | Class II | 2026-06-15 |
| K253172 | MediAI-OA | Crescom Co., Ltd. | QIH | Class II | 2026-06-15 |
| K253825 | Saige-Dx | DeepHealth, Inc. | QDQ | Class II | 2026-06-15 |
| K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | MQB | Class II | 2026-06-12 |
| K252937 | ThinkQA 3 | Dosisoft SA | IYE | Class II | 2026-06-12 |
| K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | QIH | Class II | 2026-06-12 |
| K261213 | Medical Monitor (40HT513D) | Lg Electronics.Inc | PGY | Class II | 2026-06-12 |
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | QIH | Class II | 2026-06-11 |
| K260174 | PROBEAT-CR | Hitachi High-Tech Corp. | LHN | Class II | 2026-06-11 |
| K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | OAS | Class II | 2026-06-11 |
| K253192 | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | SAO | Class II | 2026-06-10 |
| K260748 | ES-Series | E-Scopics | IYN | Class II | 2026-06-09 |
| K261352 | 2D Hip Planning Software | One Ortho | LLZ | Class II | 2026-06-08 |
| K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | OXO | Class II | 2026-06-05 |
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | NFJ | Class II | 2026-06-04 |
| K261519 | Sonio Suspect | Sonio | POK | Class II | 2026-06-04 |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | JAK | Class II | 2026-06-04 |
| K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | QIH | Class II | 2026-06-04 |
| K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | OAS | Class II | 2026-06-04 |
| K253004 | LUNA 3D | Lap GmbH Laser Applikationen | IYE | Class II | 2026-06-04 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | LLZ | Class II | 2026-06-03 |
| K260780 | HeartFocus | Deski | QJU | Class II | 2026-06-03 |
| K252947 | HistoSonics® Planning Tool | HistoSonics, Inc. | QTZ | Class II | 2026-05-29 |
| K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | QIH | Class II | 2026-05-29 |
| K253103 | Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation | JAA | Class II | 2026-05-29 |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | IZI | Class II | 2026-05-28 |
| K254092 | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | MUE | Class II | 2026-05-28 |
| K261405 | ANDI 2.2 | Imeka Solutions, Inc. | QIH | Class II | 2026-05-28 |
| K260123 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2026-05-27 |
| K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | OEB | Class II | 2026-05-27 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | LLZ | Class II | 2026-05-27 |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | MUJ | Class II | 2026-05-27 |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | IYN | Class II | 2026-05-27 |
| K260398 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2026-05-26 |
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | 2026-05-22 |
| K252784 | eXaSkin Plus | Anatomical Geometry S.L. | MUJ | Class II | 2026-05-22 |
| K252735 | C-beam | Pulmera, Inc. | OWB | Class II | 2026-05-22 |
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | CHISON Medical Technologies Co., Ltd. | IYN | Class II | 2026-05-22 |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | QIH | Class II | 2026-05-22 |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | 2026-05-21 |
| K253720 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | Wuhan United Imaging Healthcare Co.,Ltd | IYN | Class II | 2026-05-21 |
| K260234 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | QIH | Class II | 2026-05-21 |
| K254131 | BAC | DeepHealth, Inc. | QIH | Class II | 2026-05-21 |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | JAK | Class II | 2026-05-20 |
| K252717 | MAASTRO Rectal Applicator Set | Varian Medical Systems | JAQ | Class II | 2026-05-20 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | LLZ | Class II | 2026-05-18 |
| K253935 | medXion NEXUS | medXion Technologies, Inc. | OAS | Class II | 2026-05-15 |
14,721 clearances in the Radiology panel. Data: openFDA.