# K982120: Digital Imaging System, Models Digitrex-1000 and Digitrex-2000 (Digitrex-X000 Family)

- Pathway: 510(k) (Traditional)
- Applicant: Trex Medical Corp.
- Decided: Sep 10, 1998 after 86 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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
Digital Imaging System, Model DigiTREX-X000 is a digital video processing system and is intended to be used to acquire, process, store, and retrieve video information produced by the radiographic, fluoroscopic, or special procedure systems, excluding mammography.

Source page: https://510kreport.com/device/K982120
Methodology: https://510kreport.com/methodology