Viz ICH

Primary DI

00811852030318

Basic UDI-DI Code

081185203VIZICHBG

Reference

081185203VIZICHBG

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Viz.ai

Viz ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes non-contrast CT images of the brain acquired in the acute setting, and sends notifications to a neurovascular or neurosurgical specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).