The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Brevera Biopsy System With Corlumina Imaging Technology.
| Device ID | K163052 |
| 510k Number | K163052 |
| Device Name: | Brevera Biopsy System With Corlumina Imaging Technology |
| Classification | Instrument, Biopsy |
| Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Contact | Sarah Fairfield |
| Correspondent | Sarah Fairfield HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-01 |
| Decision Date | 2017-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35420045507856 | K163052 | 000 |
| 15420045513761 | K163052 | 000 |
| 15420045513778 | K163052 | 000 |
| 15420045512863 | K163052 | 000 |
| 15420045507821 | K163052 | 000 |
| 15420045507517 | K163052 | 000 |
| 15420045507753 | K163052 | 000 |
| 15420045507760 | K163052 | 000 |
| 15420045507777 | K163052 | 000 |
| 15420045507784 | K163052 | 000 |
| 15420045507791 | K163052 | 000 |
| 15420045507807 | K163052 | 000 |
| 15420045507838 | K163052 | 000 |
| 15420045507852 | K163052 | 000 |
| 35420045507801 | K163052 | 000 |
| 35420045507832 | K163052 | 000 |
| 15420045515161 | K163052 | 000 |