# P080018: Kodak Directview Computed Radiography (CR) Mammography

- Pathway: PMA
- Applicant: Carestream Health, Inc.
- Decided: Nov 3, 2010 after 828 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K120246: Kodak Directview CR Mammography System (Using Carestream CR Mammography Cassette with SNP-M1 Screen) (2012), 0 descendants of its own
- K111646: Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General Radiography, Reader IS Carbon XL2/FCR (2011), 0 descendants of its own

## Recalls of this device
- Oct 30, 2014 · Class II · Z-0820-2015: Reduced mammographic image quality when attempting to print true size multi-format images

Source page: https://510kreport.com/device/P080018
Methodology: https://510kreport.com/methodology