K103512 is an FDA 510(k) clearance for the AFFIRM BREAST BIOPSY GUIDANCE 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 January 7, 2011, 38 days after receiving the submission on November 30, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K103512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2010 |
| Decision Date | January 07, 2011 |
| Days to Decision | 38 days |
| Submission Type | Special |
| 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 |