# K110717: Konica Minolta Xpress Digital Mammography System

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Dec 23, 2011 after 283 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P050014 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P050014: Fuji's Computed Radiography  Mammography Suite (Fcrms), Fujifilm Medical System U.S.A., Inc. (2006) Summary page 1.

## Indications for use
The Konica Minolta Xpress Digital Mammography System is a software device that is used in conjunction with a specified Konica Minolta computed radiography system, REGIUS Model 190 or REGIUS Model 210 with REGIUS Cassette Plate CP1M200 and the REGIUS Console CS-3000, and a mammography x-ray unit, to produce full field digital mammography images. The Xpress Digital Mammography software with a specified Konica Minolta computed radiography system is designed to replace screen-film based systems for the production of mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. The mammographic images can be interpreted by a qualified physician using either hard copy film or soft copy display at a workstation.

Source page: https://510kreport.com/device/K110717
Methodology: https://510kreport.com/methodology