BriefCase for ICH, PE and CSF triage

GUDID 07290018052044

BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform and image analysis algorithms for ICH, PE and CSF triage.

AIDOC MEDICAL LTD

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Primary Device ID07290018052044
NIH Device Record Keyff074f1a-4755-4756-806e-07b43ef4269d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBriefCase for ICH, PE and CSF triage
Version Model Number3.0.0
Company DUNS532230094
Company NameAIDOC MEDICAL LTD
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
GS107290018052044 [Primary]

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 Date2019-11-25
Device Publish Date2019-11-17

Devices Manufactured by AIDOC MEDICAL LTD

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07290018052211 - BriefCase Triage2023-07-24 BriefCase is a radiological computer aided triage and notification software
07290018052044 - BriefCase for ICH, PE and CSF triage2019-11-25BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform and image analysis algorithms for ICH, PE and CSF triage.
07290018052044 - BriefCase for ICH, PE and CSF triage2019-11-25 BriefCase is a radiological computer aided triage and notification software device. The device contains the software platform a
07290018052013 - BriefCase2019-10-07 BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
07290018052020 - BriefCase2019-10-07 BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage
07290018052037 - BriefCase2019-10-07 BriefCase is a radiological computer aided triage and notification software device. Software version 3.0.0 for CSF triage

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