FDA.reportPublic FDA data

BriefCase Triage

Primary DI
07290018052297
Brand
BriefCase Triage
Company
AIDOC MEDICAL LTD
Model
23.y.z
Device description
BriefCase is a radiological computer aided triage and notification software
Published
2024-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QASRadiological Computer-Assisted Triage And Notification Software
QFMRadiological Computer-Assisted Prioritization Software For Lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QASRadiological Computer-Assisted Triage And Notification SoftwareRadiology2
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190896000
K193298000
K213721000
K213886000
K214043000
K220709000
K221240000
K221314000
K221330000
K222277000
K222329000
K222692000
K230020000
K232751000
K241727000
K242837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190896000BriefCaseAidoc Medical , Ltd.2019-05-31QAS
K193298000BriefCaseAidoc Medical , Ltd.2020-06-19QAS
K213721000BriefCaseAidoc Medical , Ltd.2022-03-21QAS
K213886000BriefCaseAidoc Medical , Ltd.2022-04-26QAS
K214043000BriefCaseAidoc Medical , Ltd.2022-03-14QFM
K220709000BriefCaseAidoc Medical , Ltd.2022-10-07QAS
K221240000BriefCaseAidoc Medical , Ltd.2022-05-17QAS
K221314000BriefCaseAidoc Medical , Ltd.2022-06-03QAS
K221330000BriefCaseAidoc Medical , Ltd.2022-11-18QAS
K222277000BriefCaseAidoc Medical , Ltd.2022-08-26QAS
K222329000BriefCaseAidoc Medical , Ltd.2022-09-28QAS
K222692000BriefCaseAidoc Medical , Ltd.2022-12-05QFM
K230020000BriefCaseAidoc Medical , Ltd.2023-02-01QFM
K232751000BriefCase-TriageAidoc Medical , Ltd.2023-10-30QAS
K241727000BriefCase-TriageAidoc Medical , Ltd.2024-07-12QAS
K242837000BriefCase-TriageAidoc Medical , Ltd.2024-10-18QAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018052297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018052297072900180522977290018052297

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532230094
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018052402aiOS4.x.y2026-03-08
07290018052365BriefCase Triage24.y.z2026-02-15
07290018052280BriefCase-QuantificationBC.QTF.5.y.z2025-03-05
07290018052273BriefCase Triage22.y.z2024-11-24
07290018052235BriefCase-QuantificationBC.QTF.3.x.y2024-07-04
07290018052266BriefCase-QuantificationBC.QTF.4.x.y2024-06-04
07290018052259BriefCase Triage21.x.y2023-12-27
07290018052198aiOS3.x.y2023-07-14
07290018052211BriefCase Triage19.x.y2023-07-14
07290018052044BriefCase for ICH, PE and CSF triage3.0.02019-11-17
07290018052013BriefCase1.1.0.02019-09-01
07290018052020BriefCase2.0.02019-09-01
07290018052037BriefCase3.0.02019-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007434716Cognet AIMedcognetics IncQFM2026-05-21
B720BX360TRIAGELVO1430Triage LVOBRAINOMIX LIMITEDQAS2026-05-06
B720BX360TRIAGESTRO1430Triage StrokeBRAINOMIX LIMITEDQAS2026-05-06
00199874323862NeuroICHNEUROCAREAI INCQAS2026-04-24
08800066200589JLK-ICHJLK, Inc.QAS2026-03-25
08800066200596JLK-LVOJLK, Inc.QAS2026-03-25
08800066200602JLK-SDHJLK, Inc.QAS2026-03-25
07290018052365BriefCase TriageAIDOC MEDICAL LTDQAS2026-02-15
07290018052365BriefCase TriageAIDOC MEDICAL LTDQFM2026-02-15
B720BX360TRIAGESTRO142Triage StrokeBRAINOMIX LIMITEDQAS2026-02-03
B720BX360TRIAGESTRO141Triage StrokeBRAINOMIX LIMITEDQAS2025-11-28
04056869959023syngo.CT Brain HemorrhageSiemens Healthcare GmbHQAS2025-11-21
04056869967844Update Label 127046Siemens Healthcare GmbHQAS2025-11-21
B720BX360TRIAGELVO1410Triage LVOBRAINOMIX LIMITEDQAS2025-10-16
B720BX360TRIAGEICH1120Triage ICHBRAINOMIX LIMITEDQAS2025-10-15
B720BX360TRIAGELVO1120Triage LVOBRAINOMIX LIMITEDQAS2025-10-15
B720BX360TRIAGEICH1400Triage ICHBRAINOMIX LIMITEDQAS2025-08-18
B720BX360TRIAGELVO1400Triage LVOBRAINOMIX LIMITEDQAS2025-08-18
B720BX360TRIAGESTRO1400Triage StrokeBRAINOMIX LIMITEDQAS2025-08-18
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G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQFM2025-07-28
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-24
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-24
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-02
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-02
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