510(k) K013290 ยท IZH System, X-Ray, Mammographic
MODIFIED 650 MAMMOGRAPHY SYSTEM
| Applicant | Lorad, A Hologic Co., Danbury CT, US |
| Decision | Substantially Equivalent, Oct 24, 2001 |
| Received | Oct 2, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013290
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.