K153486 is an FDA 510(k) clearance for the Affirm Prone Biopsy System. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on April 1, 2016, 119 days after receiving the submission on December 4, 2015.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K153486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2015 |
| Decision Date | April 01, 2016 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZH — System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |