# K010390: Acist Angiographic Injection System, Model R2000-CMS

- Pathway: 510(k) (Special)
- Applicant: Acist Medical Systems, Inc.
- Decided: Mar 9, 2001 after 28 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 10, 2008 · Not classified · Z-0643-2009: Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an in

Source page: https://510kreport.com/device/K010390
Methodology: https://510kreport.com/methodology