# K033637: Medical Image Digitizer, Model 2908

- Pathway: 510(k) (Special)
- Applicant: Array Corp.
- Decided: Dec 17, 2003 after 28 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Model 2908 is an image scanner which reads black and white Images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer. This device has no patient contacting materials and Is Intended to be used by trained personnel only. The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and Intervention In case of malfunction.

Source page: https://510kreport.com/device/K033637
Methodology: https://510kreport.com/methodology