K161575 is an FDA 510(k) clearance for the Affirm Lateral Arm Upright Biopsy Accessory. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Hologic (Danbury, US). The FDA issued a Cleared decision on August 10, 2016, 64 days after receiving the submission on June 7, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K161575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2016 |
| Decision Date | August 10, 2016 |
| Days to Decision | 64 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 |