# K123530: Mammography Prior Enhancement (Mpe)

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Dec 20, 2012 after 34 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091368: R2 Digitalnow HD (Digitalnow HD), Hologic, Inc. (2009) Summary page 1.

## Indications for use
Mammography Prior Enhancement (MPE) is a software application intended to enhance the appearance of prior non-Hologic digital mammography x-ray images so that they mare closely resemble Hologic digital mammography images. MFE-proccsscd images are intended for comparison purposes only and cannot be used for primary diagnosis. MPE runs on a Windows-based computer. Results can be displayed on a workstation capable of displaying mammography x-ray images, such as Hologic's SecurViewe DX wvorkstation.

Source page: https://510kreport.com/device/K123530
Methodology: https://510kreport.com/methodology