# K063424: Film Digitzer, Model 2908 Mammo Pro

- Pathway: 510(k) (Traditional)
- Applicant: Array Corp.
- Decided: Dec 21, 2006 after 38 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- 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 no predicate by number.

## Indications for use
Model 2908 Mammo pro is intended for covering analog Medical x-ray films to digital images. The device is indicated for the digitization of mammography Imaged for review and analysis, but not as-the sole basis for screening or diagnosis. The device is indicated for the digitization of mammography images for storage and display not for primary image diagnosis.

Source page: https://510kreport.com/device/K063424
Methodology: https://510kreport.com/methodology