510(k) K242783 ยท PSY Whole Slide Imaging System
Roche Digital Pathology Dx
| Applicant | Ventana Medical Systems, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Dec 17, 2024 |
| Received | Sep 16, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242783
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Ventana Medical Systems, Inc. navify Digital Pathology (on-prem) v2.5, Material Number 10092343001
navify Digital Pathology (Cloud) v2.5. Material Number 09453733001
UDI-DI Code: 761333602095AQ
In the United States, navify Dig Open, Classified |
PSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.