510(k) K173576 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Pristina Serena
| Applicant | GE Healthcare, Buc, FR |
| Decision | Substantially Equivalent, May 14, 2018 |
| Received | Nov 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2025 | GE Medical Systems, LLC Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography Open, Classified |
MUE | None listed |
| Feb 8, 2024 | GE Medical Systems, SCS Senographe Pristina Open, Classified |
MUE | None listed |
| May 16, 2019 | GE Healthcare, LLC GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions. Terminated |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.