# K232686: CorVista® System

- Pathway: 510(k) (Traditional)
- Applicant: Corvista Health, Inc.
- Decided: Sep 8, 2023 after 7 days
- Product code: QXX (Coronary Artery Disease Machine Learning-Based Notification Software)
- Device class: 2
- Regulation: 21 CFR 870.2380
- 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 DEN230003 (2023). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230003: Viz HCM, Viz. Ai, Inc. (2023) Summary page 5.

## Most influential descendants
- K233666: CorVista System with PH Add-On (2024), 2 descendants of its own
- K253699: Tempus ECG-PH (2026), 0 descendants of its own
- K253576: CorVista System® with PCWP Add-On (2026), 0 descendants of its own

## Indications for use
The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient’s signs, symptoms, and clinical history as an aid in diagnosis.

Source page: https://510kreport.com/device/K232686
Methodology: https://510kreport.com/methodology