# K040378: Kodak Directview CR Cassette/GP/15 X 30 CM, Catalog# 8418253

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: May 24, 2004 after 97 days
- Product code: IXA (Cassette, Radiographic Film)
- Device class: 2
- Regulation: 21 CFR 892.1850
- 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 K925997 (1992). 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)
- K925997: Kodak Ektascan SP Cassette, Eastman Kodak Company (1992) Summary page 2.

## Indications for use
The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.

Source page: https://510kreport.com/device/K040378
Methodology: https://510kreport.com/methodology