# K982814: Medrad Vistron CT Injector System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Oct 9, 1998 after 59 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: 1 generation back to K934086 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934086: Medrad Envision CT Injector and Qwik Fit Syringe, Medrad, Inc. (1995) Summary page 1.

## Most influential descendants
- K991557: Medrad Vistron CT Injector System (1999), 0 descendants of its own

## 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/K982814
Methodology: https://510kreport.com/methodology