510(k) K202335 ยท LLZ System, Image Processing, Radiological
Ambra ProViewer
| Applicant | Dicom Grid Inc Dba Ambra Health, New York NY, US |
| Decision | Substantially Equivalent, Sep 4, 2020 |
| Received | Aug 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2022 | DICOM Grid, Inc. d/b/a Ambra Health Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images. Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.