# K981880: DX-480, Add on Digital Imager

- Pathway: 510(k) (Traditional)
- Applicant: Wuestec Medical, Inc.
- Decided: Oct 20, 1998 after 145 days
- Product code: KPR (System, X-Ray, Stationary)
- 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.

Source page: https://510kreport.com/device/K981880
Methodology: https://510kreport.com/methodology