# K223322: Argus Cognitive ReVISION Software

- Pathway: 510(k) (Traditional)
- Applicant: Argus Cognitive, Inc.
- Decided: Jul 24, 2023 after 266 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K935595 (1995). 112 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150122: Tomtec-Arena TTA2, Tomtec Imaging Systems GmbH (2015) Summary page 5.

## Most influential descendants
- K251417: ReVISION 2 (2026), 0 descendants of its own

## Indications for use
Indications for use of the Argus Cognitive ReVISION Software are quantification and reporting of right ventricle (RV) structures and function of patients (adults only) with suspected disease to support physicians’ diagnosis.

Source page: https://510kreport.com/device/K223322
Methodology: https://510kreport.com/methodology