# K251417: ReVISION 2

- Pathway: 510(k) (Traditional)
- Applicant: Argus Cognitive, Inc.
- Decided: Sep 9, 2026 after 490 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 19 generations back to K935595 (1995). 147 ancestors in all.
No later device cites it as a predicate yet.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201632: Tomtec-Arena, Tomtec Imaging Systems GmbH (2020) Summary page 6.
- K223322: Argus Cognitive ReVISION Software, Argus Cognitive, Inc. (2023) Summary page 6.

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

Source page: https://510kreport.com/device/K251417
Methodology: https://510kreport.com/methodology