K202294 is an FDA 510(k) clearance for the Affirm Contrast Biopsy. 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 October 5, 2020, 53 days after receiving the submission on August 13, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K202294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2020 |
| Decision Date | October 05, 2020 |
| Days to Decision | 53 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 |