The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Mammography Prior Enhancement (mpe).
| Device ID | K123530 |
| 510k Number | K123530 |
| Device Name: | MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) |
| Classification | System, Image Processing, Radiological |
| Applicant | HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810 |
| Contact | Gail Yaeker-daunis |
| Correspondent | Gail Yaeker-daunis HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-16 |
| Decision Date | 2012-12-20 |
| Summary: | summary |