# K984414: Xre Collimator with Spectral Filter

- Pathway: 510(k) (Traditional)
- Applicant: Trex Medical Corp.
- Decided: Dec 30, 1998 after 20 days
- Product code: IZW (Collimator, Automatic, Radiographic)
- Device class: 2
- Regulation: 21 CFR 892.1610
- 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 XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.

Source page: https://510kreport.com/device/K984414
Methodology: https://510kreport.com/methodology