# K051258: Kodak Directview DR 7500 System, Model 8791345

- Pathway: 510(k) (Special)
- Applicant: Eastman Kodak Company
- Decided: Jun 1, 2005 after 16 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091889: DRX-Evolution, Model VX3733-Sys (2009), 30 descendants of its own
- K141837: DRX-Evolution (2015), 29 descendants of its own
- K160997: GC85A (2016), 26 descendants of its own
- K163115: GC70 (2016), 23 descendants of its own
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own

## Recalls of this device
- Jul 9, 2014 · Class II · Z-2177-2014: An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engi
- Dec 26, 2013 · Class II · Z-0844-2014: Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
- Nov 25, 2013 · Class II · Z-0798-2014: Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
- Mar 6, 2007 · Not classified · Z-0738-2007: The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication

## Indications for use
The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Source page: https://510kreport.com/device/K051258
Methodology: https://510kreport.com/methodology