# K123873: Contrast Enhanced Digital Mammography

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jan 29, 2013 after 43 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P990066 (2000). 2 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103485: Senograph DS, Senograph Essenstial, General Electric Company (2011) Summary page 1.

## Most influential descendants
- K173408: Mammomat Revelation (2018), 6 descendants of its own
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own
- K233539: MAMMOMAT B.brilliant (2024), 1 descendant of its own
- K254090: I-View® (2026), 0 descendants of its own
- K253678: MAMMOMAT B.brilliant (11372950) (2026), 0 descendants of its own

## Recalls of this device
- Dec 6, 2018 · Class II · Z-0685-2019: Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

## Indications for use
Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion.

Source page: https://510kreport.com/device/K123873
Methodology: https://510kreport.com/methodology