510(k) K123995 ยท MUE Full Field Digital, System, X-Ray, Mammographic
MICRODOSE SI
| Applicant | Philips Digital Mammography Sweden AB, Solna, SE |
| Decision | Substantially Equivalent, Feb 1, 2013 |
| Received | Dec 26, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123995
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.