# K252653: ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems, Inc.
- Decided: May 13, 2026 after 264 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: 5 generations back to K822536 (1982). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171646: ACISTCVi® Contrast Delivery System, Acist Medical Systems, Inc. (2018) Summary page 5.

## Indications for use
The ACIST Pro Diagnostic System is indicated for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures.

Source page: https://510kreport.com/device/K252653
Methodology: https://510kreport.com/methodology