# K001341: DR5000 Dedicated Chest X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corp.
- Decided: Jun 2, 2000 after 36 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033345: AN5150 and AN7150 Digital Radiology Systems (2003), 3 descendants of its own
- K040995: Synerad Multi Digital X-Ray System, Model AN6150 (2004), 2 descendants of its own
- K043025: Synerad Omni, Digital X-Ray System, Model AN6250 (2004), 1 descendant of its own
- K071430: Synerad Omni, Models AN6255 and AN6265 (2007), 0 descendants of its own

## Recalls of this device
- Oct 20, 2005 · Not classified · Z-0274-06: Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
- Feb 20, 2004 · Not classified · Z-0728-04: Defective component in overhead tube support balancer may cause the suspended load to fall.

Source page: https://510kreport.com/device/K001341
Methodology: https://510kreport.com/methodology