Company profile

Viz.ai, Inc.

Viz.ai, Inc. has 10 AI-enabled medical devices on the FDA list. The first decision was on April 20, 2018 and the most recent on June 10, 2025 (Viz Subdural+, Viz SUBDURAL PLUS). Its most common review panel is Radiology (9 devices).

10AI devices

2018First decision

2025Latest decision

2Specialties

Per year

2018202020212022202320242025

Viz.ai, Inc. AI devices per year: 2018 1, 2020 1, 2021 1, 2022 4, 2023 1, 2024 1, 2025 1

By specialty

Radiology9
Cardiovascular1

Related guides

Top radiology devices

Timeline

June 10, 2025 · 510(k) K250354Viz Subdural+, Viz SUBDURAL PLUS · Radiology · QIH
February 5, 2024 · 510(k) K232363Viz HDS, Viz Volume Plus, Viz ICH+ · Radiology · QIH
August 3, 2023 · De Novo DEN230003Viz HCM · Cardiovascular · QXO
October 21, 2022 · 510(k) K223042Viz LVO ContaCT · Radiology · QAS
August 29, 2022 · 510(k) K221100Viz RV/LV · Radiology · QIH
July 25, 2022 · 510(k) K220439Viz SDH · Radiology · QAS
February 18, 2022 · 510(k) K213319Viz ANEURYSM, Viz ANX · Radiology · QFM
March 23, 2021 · 510(k) K210209Viz ICH · Radiology · QAS
March 18, 2020 · 510(k) K193658Viz ICH · Radiology · QAS
April 20, 2018 · 510(k) K180161Viz CTP · Radiology · LLZ