# K991557: Medrad Vistron CT Injector System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Jul 21, 1999 after 78 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934086 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982814: Medrad Vistron CT Injector System, Medrad, Inc. (1998) Summary page 1.

## Indications for use
The Vistron CT Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for diagnostic studies in computed tomography.

Source page: https://510kreport.com/device/K991557
Methodology: https://510kreport.com/methodology