# K021829: Modification to Kodak Directview CR 800/900 System

- Pathway: 510(k) (Special)
- Applicant: Eastman Kodak Company
- Decided: Jul 2, 2002 after 28 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kodak DirectView CR 800/900 System: named in the summary without a submission number

## Most influential descendants
- K073670: Kodak Point of Care CR 120, Kodak Point of Care  CR 140, Kodak Point of Care CR 260 (2008), 1 descendant of its own
- K192894: Vita Flex CR System with LLI (2020), 0 descendants of its own

## Indications for use
The KODAK DirectView CR Long-Length Imaging System is used with the KODAK DirectView CR 800/ CR 900 Systems which are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiology applications. The Long-Length Imaging feature is used for examinations of long areas of anatomy such as the leg and spine.

Source page: https://510kreport.com/device/K021829
Methodology: https://510kreport.com/methodology