510(k) K231360 ยท LLZ System, Image Processing, Radiological
Ambra PACS
| Applicant | Dicom Grid Dba Ambra Health, New York NY, US |
| Decision | Substantially Equivalent, Jun 7, 2023 |
| Received | May 10, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231360
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | DICOM Grid, Inc. Intelerad InteleShare software, with ProViewer component Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.