FDA.reportPublic FDA data

BriefCase Triage

Primary DI
07290018052365
Brand
BriefCase Triage
Company
AIDOC MEDICAL LTD
Model
24.y.z
Device description
BriefCase is a radiological computer aided triage and notification software
Published
2026-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K193298000
K214043000
K220709000
K221240000
K221314000
K221330000
K222329000
K222692000
K230020000
K232751000
K241727000
K242837000
K250248000
K251195000
K251406000
K252970000
K253265000
K253578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193298000BriefCaseAidoc Medical , Ltd.2020-06-19QAS
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
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
K250248000BriefCase-TriageAidoc Medical , Ltd.2025-02-14QAS
K251195000BriefCase-TriageAidoc Medical , Ltd.2026-01-27QAS
K251406000BriefCase-TriageAidoc Medical , Ltd.2025-05-30QAS
K252970000BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical , Ltd.2026-01-07QAS
K253265000BriefCase-TriageAidoc Medical , Ltd.2025-11-06QAS
K253578000BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , Ltd.2026-02-26QAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018052365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018052365072900180523657290018052365

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).

Regulatory Flags#

DUNS number
532230094
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018052402aiOS4.x.y2026-03-08
07290018052280BriefCase-QuantificationBC.QTF.5.y.z2025-03-05
07290018052273BriefCase Triage22.y.z2024-11-24
07290018052297BriefCase Triage23.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

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Primary DI, Brand, Company table
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08800066200589JLK-ICHJLK, Inc.QAS2026-03-25
08800066200596JLK-LVOJLK, Inc.QAS2026-03-25
08800066200602JLK-SDHJLK, Inc.QAS2026-03-25
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 LTDQFM2025-07-24
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-24
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-02
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B761R60RapidIschemaview, Inc.QAS2025-05-07
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