# K060550: Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386

- Pathway: 510(k) (Special)
- Applicant: Eastman Kodak Company
- Decided: Mar 31, 2006 after 29 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 3 (0 Class I)
- 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.

## Recalls of this device
- Jan 6, 2020 · Class II · Z-0806-2020: Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
- Dec 21, 2007 · Not classified · Z-0731-2008: Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after
- Mar 6, 2007 · Not classified · Z-0717-2007: 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 3000 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/K060550
Methodology: https://510kreport.com/methodology