510(k) K232686

Device

CorVista® System

Applicant

Corvista Health, Inc.

510(k) number

K232686

Product code

QXX

Decision

Substantially Equivalent (SESE)

Decision date

2023-09-08

Date received

2023-09-01

Regulation

870.2380

Classification name

Coronary Artery Disease Machine Learning-Based Notification Software

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No