FDA-cleared K180161

Viz CTP

Viz.ai, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2018-04-20
FDA-cleared K193658

Viz ICH

Viz.ai, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-03-18
FDA-cleared K210209

Viz ICH

Viz.ai, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2021-03-23
FDA-cleared K220439

Viz SDH

Viz.ai, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-07-25
FDA-cleared K221100

Viz RV/LV

Viz.ai, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-29
FDA-cleared K223042

Viz LVO ContaCT

Viz.ai, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality
CT/CTA
Anatomy
Brain
Decision
2022-10-21
FDA-cleared K223443

Viz AAA

Viz. ai, Inc.

Image analysis/processing.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-03-17