510(k) K161575 ยท IZH System, X-Ray, Mammographic
Affirm Lateral Arm Upright Biopsy Accessory
| Applicant | Hologic, Danbury CT, US |
| Decision | Substantially Equivalent, Aug 10, 2016 |
| Received | Jun 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161575
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2017 | Hologic, Inc. Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 Terminated |
OIJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.