# K962896: Kodak Digital Science Remote Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Sep 20, 1996 after 57 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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
The user will enter Exam Information and/or display Patieht information from HIS/RIS at one of the RCIS terminal(s). This information will be transmitted via a network to the primary Quality Control Workstation of the CR-400 System. The primary QCW will update other QCW's and their respective KESPR Readers. After the phosphor cassette containing the Latent Image is scanned by a KESPR Reader the images are transmitted to a workstation which allows for the proper display of the images for diagnostic purposes. The information stored in the Readers and the will be updated by removing Exam and Patient Information. The phosphor readers are not for supporting or sustaining human life, nor do they present a potential for unreasonable risk for illness or injury.

Source page: https://510kreport.com/device/K962896
Methodology: https://510kreport.com/methodology