Viz RV/LV— 510(k) K221100

Substantially Equivalent

Viz. Ai, Inc.

FDA 510(k) clearance K221100 for Viz RV/LV, Substantially Equivalent on 2022-08-29. Applicant: Viz. Ai, Inc.. Device class: 2.

Clearance details

Applicant: Viz. Ai, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-04-14
Decision date: 2022-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

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
DEN230003 — Viz HCM2023-08-03
K223443 — Viz AAA2023-03-17
K223042 — Viz LVO ContaCT2022-10-21

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