510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230003Unknown

Viz HCM

Viz. Ai, Inc., San Francisco CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230003 is the FDA 510(k) clearance record for Viz HCM, a class II device, cleared for Viz. Ai, Inc. on under FDA product code QXO (Cardiovascular Machine Learning-Based Notification Software). FDA's definition for product code QXO reads: "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...". FDA records list 11 510(k) clearances for Viz. Ai, Inc., from to . As of , FDA records show no recalls naming DEN230003.

Clearance record

Decision date
Received
(205 days to decision)
Product code
QXO Cardiovascular Machine Learning-Based Notification Software
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Applicant
Viz. Ai, Inc. 201 Mission St., 12th Floor, San Francisco CA
Third party review
No

Clearances, product code QXO

Trailing 12 months
1 clearance under product code QXO in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QXO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260