Cleared Traditional

K232686 - CorVista® System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232686 · Corvista Health, Inc. · Cardiovascular device
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Sep 2023
Decision
7d
Days
Class 2
Risk

K232686 is an FDA 510(k) clearance for the CorVista® System. Classified as Coronary Artery Disease Machine Learning-based Notification Software (product code QXX), Class II - Special Controls.

Submitted by Corvista Health, Inc. (Washington, US). The FDA issued a Cleared decision on September 8, 2023 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2380 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Corvista Health, Inc. devices

Submission Details

510(k) Number K232686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2023
Decision Date September 08, 2023
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QXX Coronary Artery Disease Machine Learning-based Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2380
Definition Coronary Artery Disease Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Coronary Artery Disease For Further Referral Or Diagnostic Follow-up.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.