Triage Stroke

GUDID B720BX360TRIAGESTRO1120

BRAINOMIX LIMITED

X-ray image interpretive software
Primary Device IDB720BX360TRIAGESTRO1120
NIH Device Record Keyd3f5687a-aa93-4357-832e-51958b02799f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriage Stroke
Version Model Number11.2
Company DUNS216967482
Company NameBRAINOMIX LIMITED
Device Count1
DM Exemptfalse
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
HIBCCB720BX360TRIAGESTRO1120 [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 Date2023-12-15
Device Publish Date2023-12-07

Devices Manufactured by BRAINOMIX LIMITED

B720BX360ELUNG100 - e-Lung2024-06-24
B720BX360TRIAGESTRO1120 - Triage Stroke2023-12-15
B720BX360TRIAGESTRO1120 - Triage Stroke2023-12-15
B720BX360TRIAGELVO1110 - Triage LVO2023-10-11
B720BX360EMRI1110 - e-MRI2023-09-13
B720BX360TRIAGEICH1110 - Triage ICH2023-09-13
B720BX360ECTP1110 - e-CTP2023-07-14
B720BX360EASPECTS1110 - e-ASPECTS2023-04-14
B720BX360ECTA1110 - e-CTA2023-04-14

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