FDA-cleared K211788

HALO

Nico.Lab B.V.

HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard...

Modality
CT/CTA
Anatomy
Brain
Decision
2021-07-08
FDA-cleared K200873

HALO

NICo-Lab B.V.

HALO analyzes contrast-enhanced brain CTA in the acute setting for suspected anterior-circulation large-vessel occlusion and provides notification support for emergency stroke...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-11-20