The following data is part of a premarket notification filed by Hologic, Inc with the FDA for Eviva Stereotactic Guided Breast Biopsy System.
| Device ID | K180233 |
| 510k Number | K180233 |
| Device Name: | Eviva Stereotactic Guided Breast Biopsy System |
| Classification | Instrument, Biopsy |
| Applicant | Hologic, Inc 250 Campus Drive Marlborough, MA 01752 |
| Contact | Brenda M Geary |
| Correspondent | Brenda M Geary 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 | 2018-01-29 |
| Decision Date | 2018-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045505339 | K180233 | 000 |
| 15420045505322 | K180233 | 000 |
| 15420045504998 | K180233 | 000 |
| 15420045504981 | K180233 | 000 |
| 15420045504974 | K180233 | 000 |
| 15420045504950 | K180233 | 000 |
| 15420045504943 | K180233 | 000 |
| 15420045504936 | K180233 | 000 |