510(k) K162268 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Senographe Pristina
| Applicant | GE Healthcare, Buc, FR |
| Decision | Substantially Equivalent, Nov 3, 2016 |
| Received | Aug 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162268
| 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 Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended Terminated |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.