The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Contrast Enhanced Digital Mammography.
| Device ID | K123873 |
| 510k Number | K123873 |
| Device Name: | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Deborah Thomas |
| Correspondent | Deborah Thomas HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-17 |
| Decision Date | 2013-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045512016 | K123873 | 000 |
| 15420045512665 | K123873 | 000 |
| 15420045512658 | K123873 | 000 |
| 15420045512641 | K123873 | 000 |