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 |
|---|---|---|---|
| K261531 | PV-iCurve Pro | Perception Vision Medical Technology Co., Ltd. | 2026-10-21 |
| K261788 | Eden PACS | Higia., Inc. d/b/a Eden | 2026-10-21 |
| K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | 2026-09-29 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B745ELUCIDB1P1 | Elucid Plaque-IQ | ELUCID BIOIMAGING INC. | 2026-10-29 |
| 04719878712002 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2026-10-28 |
| 00889024671270 | ROSA® Hip | Orthosoft Inc | 2026-10-27 |
| 07290115750799 | Long drill guide and Long Cannula | MAZOR ROBOTICS LTD | 2021-08-18 |
| 07290115750782 | Long drill 4x80mm,10 pack | MAZOR ROBOTICS LTD | 2021-08-18 |
| 07290115750775 | Short Drill 3x30mm,10 pack | MAZOR ROBOTICS LTD | 2021-08-18 |
| 07290115750768 | Long Drill 3.0x30, 10 pack | MAZOR ROBOTICS LTD | 2021-08-18 |
| 07290115750751 | Auxiliary Drill Guide And Auxiliary Cannula | MAZOR ROBOTICS LTD | 2021-08-18 |
| 07290115750744 | Head Pin 2.5x60mm,10 pack | MAZOR ROBOTICS LTD | 2021-08-18 |
| 07290115750737 | Schanz screw 4mmx80, 10 pack | MAZOR ROBOTICS LTD | 2021-08-18 |
| 07290109184722 | StarDriver Kit | MAZOR ROBOTICS LTD | 2021-05-18 |
| 07290109184777 | Snapshot Tracker Kit | MAZOR ROBOTICS LTD | 2021-05-18 |
| 07290109184784 | Robotic Frame Connection Kit | MAZOR ROBOTICS LTD | 2021-05-18 |
| 07290109184845 | Mazor X Navigation Camera | MAZOR ROBOTICS LTD | 2021-05-18 |
| 07290109184982 | Lateral Optional Kit | MAZOR ROBOTICS LTD | 2021-05-18 |
| 07290109184876 | Auxiliary Drill Guide And Auxiliary Cannula | MAZOR ROBOTICS LTD | 2021-02-28 |
| 07290109184913 | Long drill guide and Long Cannula | MAZOR ROBOTICS LTD | 2021-02-28 |
| 07290109184944 | Short Drill 3x80mm,10 pack | MAZOR ROBOTICS LTD | 2021-02-28 |
| 07290109184906 | Long drill 4x80mm,10 pack | MAZOR ROBOTICS LTD | 2021-02-15 |
| 07290109184920 | Short Drill Guide and Short Cannula | MAZOR ROBOTICS LTD | 2021-02-15 |
| 07290109184937 | Long drill 3x80mm,10 pack | MAZOR ROBOTICS LTD | 2021-02-15 |
| 07290109184968 | Surgeon's screen Sterile Sleeve,10 pack | MAZOR ROBOTICS LTD | 2021-01-27 |
| 07290109184951 | Head Pin 2.5x100mm,10 pack | MAZOR ROBOTICS LTD | 2021-01-27 |
| 07290109184883 | Long Drill 3.0x30, 10 pack | MAZOR ROBOTICS LTD | 2021-01-14 |
| 07290109184975 | Sterile Clear Sleeve,10 pack | MAZOR ROBOTICS LTD | 2021-01-07 |
| 07290109184852 | Schanz screw 4mmx80,10 pack | MAZOR ROBOTICS LTD | 2021-01-03 |
| 07290109184869 | Head Pin 2.5x60mm,10 pack | MAZOR ROBOTICS LTD | 2021-01-03 |
| 07290109184890 | Short Drill 3x30mm,10 pack | MAZOR ROBOTICS LTD | 2021-01-03 |
| 07290109184555 | Mazor X Surgical Instruments | MAZOR ROBOTICS LTD | 2021-01-03 |
| 00842000100737 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | 2018-11-15 |