# K984058: Acist Injector System, Model CL100 H

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems
- Decided: Feb 11, 1999 after 90 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- 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 K822536 (1982). 2 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963982: Acist Angiographic Injector, Invasatec (1997) Summary page 1.

## Most influential descendants
- K991103: Modification to Acist CL 100H (2000), 19 descendants of its own
- 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

## Indications for use
The ACIST System from Invasatec is intended to be used for the controlled infusion of radio-opaque contrast media for angiographic procedures.

Source page: https://510kreport.com/device/K984058
Methodology: https://510kreport.com/methodology