# K993774: Acist Angiographic Injection System, Model CL1OOH

- Pathway: 510(k) (Special)
- Applicant: Acist Medical Systems
- Decided: Dec 7, 1999 after 29 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices 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) Acist® Angiographic Injection System, Model CL100H without the “RESUME?” feature: named in the summary without a submission number

## Most influential descendants
- K131478: Contrast Conservation System (2013), 13 descendants of its own
- K140425: Contrast Modulation System (2014), 12 descendants of its own
- K150485: AVERT Contrast Modulation System (2015), 10 descendants of its own
- K151300: AVERT Contrast Modulation System (2015), 8 descendants of its own
- K151746: Dyevert Contrast Modulation System (2015), 8 descendants of its own

## Indications for use
The Acist Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Source page: https://510kreport.com/device/K993774
Methodology: https://510kreport.com/methodology