Circle Neurovascular Imaging Inc

Address:800 5 Ave SW,Calgary Alberta,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Radiological Computer-Assisted Triage And Notification Software (QAS) (1)

Premarket Exempt

Clear

StrokeSENS - B926SSSX10 Catalog Number :

Device Description : StrokeSENS LVO is a radiological computer-aided triage and notification software StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.

Device Class : 2

Duns Number: 204127042

Premarket Exempt : No

Product Code : QAS

Prescription Use : Yes

Device Count : 1

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