# K233666: CorVista System with PH Add-On

- Pathway: 510(k) (Traditional)
- Applicant: Analytics For Life, Inc.
- Decided: Apr 5, 2024 after 142 days
- Product code: SAT (Pulmonary Hypertension 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: 2 generations back to DEN230003 (2023). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K232686: CorVista® System, Corvista Health, Inc. (2023) Summary page 5.

## Most influential descendants
- 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 provide a binary output indicating the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. 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/K233666
Methodology: https://510kreport.com/methodology