# K963982: Acist Angiographic Injector

- Pathway: 510(k) (Traditional)
- Applicant: Invasatec
- Decided: Dec 5, 1997 after 429 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 K822536 (1982). 1 ancestor in all.
23 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822536: MARK V, Medrad, Inc. (1982) Summary page 2.
- (no number) Mark V+: named in the summary without a submission number

## Most influential descendants
- K984231: Angiographic Contrast Management System, Model Part a and Part B (2000), 20 descendants of its own
- K984058: Acist Injector System, Model CL100 H (1999), 20 descendants of its own
- K991103: Modification to Acist CL 100H (2000), 19 descendants of its own
- K052744: C2000 Automated Manifold Kit (2005), 14 descendants of its own
- K131478: Contrast Conservation System (2013), 13 descendants of its own

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

Source page: https://510kreport.com/device/K963982
Methodology: https://510kreport.com/methodology