# K120246: Kodak Directview CR Mammography System (Using Carestream CR Mammography Cassette with SNP-M1 Screen)

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Aug 28, 2012 after 214 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 P080018 (2010). 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)
- P080018: Kodak Directview Computed Radiography (CR) Mammography, Carestream Health, Inc. (2010) Summary page 1.
- (no number) CR Mammography Cassette with EHR-M3 Screen: named in the summary without a submission number

## Indications for use
The KODAK DirectView CR Mammography Feature together with KODAK DirectView CR Mammography Cassette comprise a device which, when used in conjunction with a KODAK DirectView CR System and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

Source page: https://510kreport.com/device/K120246
Methodology: https://510kreport.com/methodology