StrokeSENS

GUDID B926SSSX10

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.

Circle Neurovascular Imaging Inc

CT system application software
Primary Device IDB926SSSX10
NIH Device Record Key53482d8b-5336-4b20-8b7b-48b1c888e3ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameStrokeSENS
Version Model Numberv1.x
Company DUNS204127042
Company NameCircle Neurovascular Imaging Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB926SSSX10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QASRadiological Computer-Assisted Triage And Notification Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-07
Device Publish Date2022-08-30

Trademark Results [StrokeSENS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STROKESENS
STROKESENS
88848543 not registered Live/Pending
Circle Cardiovascular Imaging Inc.
2020-03-26

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