# K020892: Acist Gentoo Contrast Injection System

- Pathway: 510(k) (Abbreviated)
- Applicant: Acist Medical Systems
- Decided: Jan 27, 2003 after 314 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
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. The FDA summary names its predicate without a number.
- (no number) Medrad Envision CT Injection System and Disposable Kit: named in the summary without a submission number
- (no number) Acist CMS2000 Angiographic Injection System Disposable Kits: named in the summary without a submission number

## Indications for use
The Acist GENTOO Contrast Injection System for Computed Tomography is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature during computed tomography applications.

Source page: https://510kreport.com/device/K020892
Methodology: https://510kreport.com/methodology