# K022810: Cobrascan CR-1 Filmless

- Pathway: 510(k) (Traditional)
- Applicant: Radiographic Digital Imaging, Inc.
- Decided: Oct 11, 2002 after 49 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
Longest line of descent: 1 generation back to K953942 (1995). 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)
- K953942: Cobrascan CX-312, Radiographic Digital Imaging, Inc. (1995) Summary page 3.

## Indications for use
The indications for use of the Cobrascan CR-1 Filmless is: the identification, capture, digitization and processing of diagnostic x-ray images from x-ray film and from phosphor imaging plates.

Source page: https://510kreport.com/device/K022810
Methodology: https://510kreport.com/methodology