510(k) DEN230003

Viz HCM by Viz. Ai, Inc. — Product Code QXO

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: August 3, 2023
Date Received: January 10, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cardiovascular Machine Learning-Based Notification Software
Device Class: Class II
Regulation Number: 870.2380
Review Panel: CV
Submission Type

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.

Other clearances by Viz. Ai, Inc.

K250354 — Viz Subdural+, Viz SUBDURAL PLUS (June 10, 2025)
K232363 — Viz HDS, Viz Volume Plus, Viz ICH+ (February 5, 2024)
K223443 — Viz AAA (March 17, 2023)
K223042 — Viz LVO ContaCT (October 21, 2022)
K221100 — Viz RV/LV (August 29, 2022)
K220439 — Viz SDH (July 25, 2022)
K213319 — Viz ANEURYSM, Viz ANX (February 18, 2022)
K210209 — Viz ICH (March 23, 2021)
K193658 — Viz ICH (March 18, 2020)
K180161 — Viz CTP (April 20, 2018)