Viz HCM— 510(k) DEN230003

Unknown

Viz. Ai, Inc.

FDA 510(k) clearance DEN230003 for Viz HCM, Unknown on 2023-08-03. Applicant: Viz. Ai, Inc.. Device class: 2.

Clearance details

Applicant: Viz. Ai, Inc.
Product code: Code QXO
Device class: Class 2
Regulation: 21 CFR 870.2380
Advisory panel: Cardiovascular
Date received: 2023-01-10
Decision date: 2023-08-03
Decision: Unknown
Clearance type: Direct
Location: San Francisco, CA, US

View on FDA.gov ↗

Recent devices under product code QXO

K260332 — EchoNext2026-06-08

More clearances from Viz. Ai, Inc.

K250354 — Viz Subdural+, Viz SUBDURAL PLUS2025-06-10
K232363 — Viz HDS, Viz Volume Plus, Viz ICH+2024-02-05
K223443 — Viz AAA2023-03-17
K223042 — Viz LVO ContaCT2022-10-21
K221100 — Viz RV/LV2022-08-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.