Product code LLZ
- Device name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.2050
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | 2026-09-23 |
| K262442 | HipStudio Analysis | Replasia BV | 2026-09-22 |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | 2026-09-18 |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2026-09-15 |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | 2026-09-15 |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | 2026-09-04 |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | 2026-08-17 |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | 2026-08-14 |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | 2026-08-12 |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| K260588 | Cleerly LABS | Cleerly, Inc. | 2026-07-29 |
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-07-24 |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026-07-23 |
| K260500 | ResolutionMD | ResolutionMD, Inc. | 2026-07-21 |
| K262120 | Avara Viewer | Avara Software | 2026-07-10 |
| K253899 | 3D-Anywhere | Provect.AI | 2026-07-09 |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04260456230215 | CHILI PACS | CHILI GmbH | 2026-09-25 |
| B141MEDISSUITEMRCT20260 | Medis Suite MRCT | Medis Medical Imaging Systems B.V. | 2026-09-25 |
| 00850025268431 | Vitrea Advanced Visualization | Canon Medical Informatics, Inc. | 2026-09-21 |
| 08437021722109 | ADAS 3D | ADAS3D MEDICAL S.L. | 2026-09-18 |
| 07350092810722 | Sectra Orthopedic Package | Sectra AB | 2026-09-06 |
| 00198953059173 | ViewPoint | GE Healthcare GmbH | 2026-02-27 |
| 00198953076873 | SenoIris | GE MEDICAL SYSTEMS | 2025-11-24 |
| 00860003424841 | OrthoGrid Hip Trauma | Orthogrid Systems, Inc. | 2025-06-24 |
| 00884838127746 | Radiology Operations Command Center Console | Philips Medical Systems Nederland B.V. | 2025-03-14 |
| 00198715251623 | BrainSpec Core™ Software | BrainSpec Inc. | 2025-02-10 |
| 00195278753472 | ViewPoint | GE Healthcare GmbH | 2024-07-15 |
| 00195278517340 | ViewPoint | GE Healthcare GmbH | 2023-02-15 |
| 00860003424834 | OrthoGrid Hip AI | Orthogrid Systems, Inc. | 2022-05-19 |
| 07649990819006 | OsiriX MD | Pixmeo Sàrl | 2022-02-19 |
| 00860003424827 | OrthoGrid Hip Trauma | Orthogrid Systems, Inc. | 2021-08-27 |
| 00860003424810 | OrthoGrid Hip Preservation | Orthogrid Systems, Inc. | 2021-03-05 |
| 00860003424803 | OrthoGrid Hip | Orthogrid Systems, Inc. | 2021-03-05 |
| 00350227000131 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2019-02-08 |
| 00350227000124 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2017-12-01 |
| 00350227000094 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2017-09-11 |
| 00350227000100 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2017-09-11 |
| 00350227000117 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2017-09-11 |
| 00350227000018 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2016-09-23 |
| 00350227000025 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2016-09-23 |
| 00350227000032 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2016-09-23 |
| 00350227000049 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2016-09-23 |
| 00350227000056 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2016-09-23 |
| 00350227000063 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2016-09-23 |
| 00350227000070 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2016-09-23 |
| 00350227000087 | EAGLESOFT | PATTERSON TECHNOLOGY CENTER | 2016-09-23 |