# K020635: Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System, Catalog# 1170976

- Pathway: 510(k) (Special)
- Applicant: Eastman Kodak Company
- Decided: Mar 21, 2002 after 22 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
88 later devices descend from it; 2 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K923544: One Touch Test Strips, Lifescan, Inc. (1992). Our OCR of the scanned summary read K923544, FDA’s number for One Touch Test Strips (Lifescan, Inc.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 2.

## Most influential descendants
- K090318: Carestream DRX-1 System (2009), 79 descendants of its own
- K100762: Flat Panel Detector, Model FDR D-Evo (2010), 55 descendants of its own
- K103596: Wireless/Wired FDR D-Evo Flat Panel Detector (2011), 54 descendants of its own
- K111548: Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE (2011), 52 descendants of its own
- K132509: FDR D-Evo Flat Panel Detector System (2013), 50 descendants of its own

## Recalls of this device
- Oct 30, 2014 · Class II · Z-0820-2015: Reduced mammographic image quality when attempting to print true size multi-format images

## Indications for use
The KODAK DirectView CR 800 System and the KODAK Direct View CR 900 System are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications.

Source page: https://510kreport.com/device/K020635
Methodology: https://510kreport.com/methodology