510(k) K003795 ยท IZH System, X-Ray, Mammographic
BIOLUCENT MAMMOGRAPHY CUSHION
| Applicant | Biolucent, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Feb 14, 2001 |
| Received | Dec 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003795
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.