FDA De Novo · Viz.ai
DEN230003: Viz HCM (Viz. Ai, Inc.)
Viz. Ai, Inc. received FDA De Novo DEN230003 for Viz HCM, with a decision date of Aug 3, 2023.
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | DEN230003 |
|---|---|
| Pathway | De Novo |
| Applicant | Viz. Ai, Inc. |
| Device name | Viz HCM |
| Product code | QXO: Cardiovascular Machine Learning-Based Notification Software |
| Regulation (21 CFR) | 870.2380 |
| Device class | Class 2 |
| Date received | Jan 10, 2023 |
| Decision date | Aug 3, 2023 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Viz HCM is indicated as follows: 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.
Extracted automatically from FDA's decision summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 3 records in this database cite DEN230003 as a predicate (listed below).
Later records that cite DEN230003
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 870.2380). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QXO is "Cardiovascular Machine Learning-Based Notification Software", class 2, 21 CFR 870.2380. FDA's 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."
Our labels for filtering: claim Other, sensor Unknown. These are heuristics, not FDA fields.