# K111324: CR Mammography System with DX-M Digitizer

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Dec 22, 2011 after 225 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fuji Computed Radiography Mammography Suite (FCRm): named in the summary without a submission number

## Indications for use
Agfa's CR Mammography System with DX-M Digitizer is indicated for use in diagnostic and screening mammography. It is intended to be used wherever conventional film/screen mammography systems are used.

Source page: https://510kreport.com/device/K111324
Methodology: https://510kreport.com/methodology