FDA 510(k) Applications Submitted by Viz.ai, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
DEN230003 01/10/2023 Viz HCM Viz.ai, Inc.
K180161 01/19/2018 Viz CTP Viz.ai, Inc.
K210209 01/26/2021 Viz ICH Viz.ai, Inc.
K250354 02/07/2025 Viz Subdural+, Viz SUBDURAL PLUS Viz.ai, Inc.
K223042 09/29/2022 Viz LVO ContaCT Viz.ai, Inc.
K213319 10/04/2021 Viz ANEURYSM, Viz ANX Viz.ai, Inc.
K193658 12/30/2019 Viz ICH Viz.ai, Inc.
K232363 08/07/2023 Viz HDS, Viz Volume Plus, Viz ICH+ Viz.ai, Inc.
K220439 02/16/2022 Viz SDH Viz.ai, Inc.
K221100 04/14/2022 Viz RV/LV Viz.ai, Inc.


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