Identity
- Trade Name
- Briefcase-Triage EUDAMED
- Device Name
- BriefCase-Triage EUDAMED
- Model / Reference
- BC.TRG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290018052310 EUDAMED
- Basic UDI-DI
- 7290018052BC.TRGSU EUDAMED
- Direct Marketing DI
- 07290018052310 EUDAMED
- 510(k) Number
- K252970 FDA 510(k)
- FDA Product Code
- QAS FDA 510(k)
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2080 FDA 510(k)
- Regulation Number
- 892.2080 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Briefcase Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT chest, abdomen, or other images. It is designed to assist with triage and prioritization of medical images. The device contains the software platform and image analysis algorithms to help radiologists prioritize medical images that need immediate attention. It is a Class IIa device with a nomenclature code of Z11069092.
Briefcase Triage is a single-use, non-implantable, and non-sterile device. It is not intended for administering medicine, and it does not contain animal tissues or latex. The device has been authorized with FDA 510K and MDR approvals. It is supplied with a unique reference code BC.TRG and a basic UDI of 7290018052BC.TRGSU.
Frequently asked questions
What is Briefcase Triage used for?
Briefcase Triage is used for radiological computer aided triage and notification, specifically for analyzing CT chest, abdomen, or other images to prioritize medical images that need immediate attention.
Is Briefcase Triage a sterile device?
No, Briefcase Triage is not a sterile device, as indicated by the specification STERILE: 0.
What are the authorizations for Briefcase Triage?
Briefcase Triage has been authorized with FDA 510K and MDR approvals, as stated in the specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: [PDF] May 30, 2025 Aidoc Medical, Ltd. John Smith Partner Hogan ..., [PDF] K180647.pdf - accessdata.fda.gov, AIDOC MEDICAL LTD - RevMed, BriefCase-Triage | FDA Radiology AI Device - X-ray Interpreter
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
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FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
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FDA_510K
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CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K261317 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252970 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K250248 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242837 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K203508 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K190072 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K243548 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222277 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222692 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221240 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K201020 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K230020 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180647 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K251406 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220709 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K214043 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232751 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221314 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221330 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K253265 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K193298 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222329 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K190896 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K241727 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K213721 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K213886 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K192383 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K251195 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7290018052BC.TRGSU | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aidoc Medical Ltd.
- EUDAMED SRN
- IL-MF-000030988
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a9fa1c62-6abd-4b8d-ba23-d050d342bbe9 61 fields · synced Sep 18, 2026
- FDA 510(k) K252970 24 fields · synced May 18, 2026