# K111649: CS 7600

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Sep 23, 2011 after 102 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934949 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060079: Kodak Model CR-7400 Digital Radiography System, Eastman Kodak Company (2006) Summary page 2.
- K041050: Digora Optime (or Digora Ontime), Soredex Palodex Group OY (2004) Summary page 2.

## Indications for use
The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging.

Source page: https://510kreport.com/device/K111649
Methodology: https://510kreport.com/methodology