FDA 510(k) ClearanceLLZ
3D-Anywhere
FDA 510(k) K253899 · Provect.AI
- 510(k) number
- K253899
- Device name
- 3D-Anywhere
- Applicant
- Provect.AI
- Product code
- LLZ
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 892.2050
- Advisory committee
- RA
- Medical specialty
- Radiology
Candidate predicate devices
Other devices cleared under product code LLZ form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | |
| K260500 | ResolutionMD | ResolutionMD, Inc. | |
| K262120 | Avara Viewer | Avara Software | |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | |
| K261352 | 2D Hip Planning Software | One Ortho | |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.