Device Atlas

CorVista System with PH Add-On

Q: What is the product code of K233666?

The FDA product code is SAT – Pulmonary Hypertension Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.

FDA 510(k) K233666 · Analytics For Life, Inc.

Substantially Equivalent

510(k) numberK233666

Submission

Device name: CorVista System with PH Add-On
Applicant: Analytics For Life, Inc.
Toronto, CA
Received: November 15, 2023
Decision date: April 5, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: SAT – Pulmonary Hypertension Machine Learning-Based Notification Software
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2380
Specialty: Cardiovascular

Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.

Other 510(k)s with product code SAT

510(k)	Device	Applicant	Decision
K253699	Tempus ECG-PHSAT · Traditional	Tempus AI, Inc.	08/21/2026SE
K252360	ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)SAT · Traditional	Anumana, Inc.	03/28/2026SE

More from Anumana, Inc.

510(k)	Device	Decision
K253576	CorVista System® with PCWP Add-OnDQK · Traditional	07/26/2026SE

Questions and answers

When was CorVista System with PH Add-On cleared by the FDA?

CorVista System with PH Add-On (K233666) received a 510(k) decision of Substantially Equivalent on April 5, 2024, 142 days after the submission was received.

What is the product code of K233666?

The FDA product code is SAT – Pulmonary Hypertension Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.