510(k) K123873 ยท MUE Full Field Digital, System, X-Ray, Mammographic
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
| Applicant | Hologic, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jan 29, 2013 |
| Received | Dec 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2018 | Hologic, Inc. I-View Contrast Enhanced Digital Mammography, ASY-08109 Terminated |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.