Not Cleared Direct

DEN230003 - Viz HCM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230003 · Viz. Ai, Inc. · Cardiovascular device
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Aug 2023
Decision
205d
Days
Class 2
Risk

DEN230003 is an FDA 510(k) submission (not cleared) for the Viz HCM. Classified as Cardiovascular Machine Learning-based Notification Software (product code QXO), Class II - Special Controls.

Submitted by Viz. Ai, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on August 3, 2023 after a review of 205 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Viz. Ai, Inc. devices

Submission Details

510(k) Number DEN230003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 10, 2023
Decision Date August 03, 2023
Days to Decision 205 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics

Device Classification

Product Code QXO Cardiovascular Machine Learning-based Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2380
Definition Cardiovascular Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Cardiovascular Disease Or Condition For Further Referral Or Diagnostic Follow-up. The Software Identifies A Single Condition Based On One Or More Non-invasive Physiological Inputs As Part Of Routine Medical Care. It Is Intended As The Basis For Further Testing And Is Not Intended To Provide Diagnostic Quality Output. It Is Not Intended To Identify Or Detect Arrhythmias.
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.