The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Affirm Breast Biopsy Guidance System.
| Device ID | K103512 |
| 510k Number | K103512 |
| Device Name: | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810 |
| Contact | Gail Yaeker-dauni |
| Correspondent | Gail Yaeker-dauni HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-30 |
| Decision Date | 2011-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045512948 | K103512 | 000 |