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 |
|---|---|---|---|
| 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 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 |
| K251577 | LAIA XR | Augmented Reality Software S.L. | 2026-02-06 |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | 2026-01-08 |
| K253639 | View | GE Healthcare | 2026-01-08 |
| K253008 | maiLink | Maihub Corp. | 2026-01-05 |
| K251883 | MIM – LesionID Pro | Mim Software, Inc. | 2025-12-11 |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | 2025-11-21 |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | 2025-11-20 |
| K251410 | VXvue | Vieworks Co., Ltd. | 2025-11-04 |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025-11-03 |
| K252547 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2025-10-28 |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | 2025-10-22 |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | 2025-10-16 |
| K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025-10-15 |
| K251363 | ProKnow DS | Elekta Solutions AB | 2025-10-08 |
| K250039 | HPACS | Healthhub | 2025-10-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 75401622522101 | Synthesis Vision Viewer | Synthesis Health Intelligence Inc | 2026-05-27 |
| 17540262200096 | Change Healthcare Stratus Imaging Diagnostic Viewer | Change Healthcare Canada Company | 2026-05-27 |
| 08437021722093 | ADAS 3D | ADAS3D MEDICAL S.L. | 2026-05-12 |
| 08033837938835 | no brand | CEFLA SOCIETA' COOPERATIVA | 2026-05-11 |
| 08437021468045 | QP-Brain® | QUIBIM SOCIEDAD LIMITADA. | 2026-05-06 |
| EOLENEUROINSIGHTV1P00 | Neuro Insight | Olea Medical USA | 2026-04-13 |
| EOLENEUROVASIV1P00 | Neurovascular Insight | Olea Medical USA | 2026-04-13 |
| 08056304455864 | Caas Qardia | Pie Medical Imaging B.V. | 2026-04-03 |
| 08437021468175 | QP-Prostate | QUIBIM SOCIEDAD LIMITADA. | 2025-07-04 |
| 07630542730153 | MyShoulder Planner | Medacta International SA | 2025-02-06 |
| 07613252286578 | FLUOROMAP | Stryker Leibinger GmbH & Co. KG | 2025-01-28 |
| 07613252286622 | FLUOROMAP | Stryker Leibinger GmbH & Co. KG | 2025-01-28 |
| 08056304455727 | G-scan Open | ESAOTE SPA | 2024-07-02 |
| 08056600520044 | Nical Flat Panel | NICAL SPA | 2023-10-09 |
| 07630542715679 | Advanced MyHip Planner | Medacta International SA | 2023-01-26 |
| 07630345729286 | Advanced MyHip Planner | Medacta International SA | 2023-01-23 |
| 07630030855849 | MyHip bone model | Medacta International SA | 2023-01-23 |
| 07630030855832 | MyHip bone model | Medacta International SA | 2023-01-23 |
| 07630030855825 | MyHip bone model | Medacta International SA | 2023-01-23 |
| 07630030855818 | MyHip bone model | Medacta International SA | 2023-01-23 |
| 07630971257603 | MyHip Planner | Medacta International SA | 2020-11-06 |
| 07630971257610 | MyHip Verifier | Medacta International SA | 2020-11-06 |
| D848CURVEIMAGE0 | Curve Image™ | Curve Dental | 2017-04-10 |
| D848CURVEHERO0 | Curve Hero™ | Curve Dental | 2017-04-10 |
| 08056477300008 | MediMatic | MEDIMATIC SRL | 2016-10-06 |
| 08056304450029 | G-scan Brio | ESAOTE SPA | 2016-09-27 |
| 07613252286677 | NA | Stryker Leibinger GmbH & Co. KG | 2016-09-15 |
| 07613252286660 | NA | Stryker Leibinger GmbH & Co. KG | 2016-09-15 |
| 07613252286653 | NA | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |
| 07613252286646 | NA | Stryker Leibinger GmbH & Co. KG | 2016-08-24 |