DEN230003 is an FDA 510(k) submission for the Viz HCM. This device is classified as a Cardiovascular Machine Learning-based Notification Software (Class II - Special Controls, product code QXO).
Submitted by Viz. Ai, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on August 3, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2380. 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..
| 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 | - |
| Product Code | QXO - Cardiovascular Machine Learning-based Notification Software |
| Device Class | Class II - 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. |