# DEN230003: Viz HCM

- Pathway: De Novo (Direct)
- Applicant: Viz. Ai, Inc.
- Decided: Aug 3, 2023 after 205 days
- Product code: QXO (Cardiovascular 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
No predicates in its family tree.
16 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K232699: Low Ejection Fraction AI-ECG Algorithm (2023), 8 descendants of its own
- K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (2025), 4 descendants of its own
- K232686: CorVista® System (2023), 3 descendants of its own
- K233666: CorVista System with PH Add-On (2024), 2 descendants of its own
- K252360: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (2026), 1 descendant of its own

## Indications for use
Viz HCM is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG made on compatible ECG devices. Viz HCM is capable of analyzing the ECG, detecting signs associated with hypertrophic cardiomyopathy (HCM), and allowing the user to view the ECG and analysis results. Viz HCM is indicated for use on 12-lead ECG recordings collected from patients 18 years of age or older. Viz HCM is not intended for use on patients with implanted pacemakers. Viz HCM is limited to analysis of ECG data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. Viz HCM identifies patients for further HCM follow-up and does not replace the current standard of care methods for diagnosis of HCM. The results of the device are not intended to rule-out HCM follow-up.

Source page: https://510kreport.com/device/DEN230003
Methodology: https://510kreport.com/methodology