The following data is part of a premarket notification filed by Hologic Inc with the FDA for Affirm Prone Biopsy System.
| Device ID | K153486 |
| 510k Number | K153486 |
| Device Name: | Affirm Prone Biopsy System |
| Classification | System, X-ray, Mammographic |
| Applicant | Hologic Inc 36 Apple Ridge Road Danbury, CT 06810 |
| Contact | Sarah Fairfield |
| Correspondent | Sarah Fairfield Hologic, Inc 36 Apple Ridge Rd. Danbury, CT 06810 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-04 |
| Decision Date | 2016-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506541 | K153486 | 000 |
| 15420045510852 | K153486 | 000 |
| 15420045510869 | K153486 | 000 |
| 15420045504721 | K153486 | 000 |
| 15420045504738 | K153486 | 000 |
| 15420045506466 | K153486 | 000 |
| 15420045506473 | K153486 | 000 |
| 15420045506480 | K153486 | 000 |
| 15420045506497 | K153486 | 000 |
| 15420045506503 | K153486 | 000 |
| 15420045506510 | K153486 | 000 |
| 15420045506527 | K153486 | 000 |
| 15420045506534 | K153486 | 000 |
| 15420045510845 | K153486 | 000 |