The following data is part of a premarket notification filed by Hologic with the FDA for Affirm Lateral Arm Upright Biopsy Accessory.
| Device ID | K161575 |
| 510k Number | K161575 |
| Device Name: | Affirm Lateral Arm Upright Biopsy Accessory |
| Classification | System, X-ray, Mammographic |
| Applicant | HOLOGIC 36 APPLE RIDGE ROAD Danbury, CT 06810 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock HOLOGIC 36 APPLE RIDGE ROAD 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 | 2016-06-07 |
| Decision Date | 2016-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506831 | K161575 | 000 |
| 15420045506824 | K161575 | 000 |
| 15420045506817 | K161575 | 000 |