← Back to catalogue

BriefCase-Triage CARE Multi-Triage CT

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253578

by Aidoc Medical Ltd

Identifiers

510(k) Number
K253578 FDA 510(k)
FDA Product Code
QAS FDA 510(k)
Models / Variants
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax FDA 510(k)EUDAMED
Pericardial effusion FDA 510(k)EUDAMED
Large aortic aneurysm FDA 510(k)EUDAMED
Shoulder fracture or dislocation device FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2080 FDA 510(k)
Regulation Number
892.2080 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BriefCase-Triage CARE Multi-Triage CT is a Radiological Computer-Assisted Triage and Notification Software designed to assist radiologists in identifying critical conditions from computed tomography (CT) scans. It specifically supports the detection of pneumothorax, pericardial effusion, large aortic aneurysm, and shoulder fracture or dislocation, enabling rapid triage decisions in emergency settings.

This software is intended for use in radiology departments within hospital or clinical environments, operating as a standalone or integrated tool within existing imaging workflows. Supplied as a digital solution, it requires no physical sterilisation but must be installed on compliant, HIPAA-compliant systems to ensure patient data security. The device is classified as Class II under FDA regulations and holds FDA 510(k) clearance and MDR authorisation, adhering to strict radiology-specific standards for diagnostic software.

Frequently asked questions

What clinical conditions does the BriefCase-Triage CARE Multi-Triage CT software help radiologists identify during CT scans?

The BriefCase-Triage CARE Multi-Triage CT software is designed to assist radiologists in rapidly identifying critical conditions from CT scans, specifically pneumothorax, pericardial effusion, large aortic aneurysms, and shoulder fractures or dislocations. This helps prioritize patient care in emergency settings by enabling faster triage decisions.

How is the BriefCase-Triage CARE Multi-Triage CT software supplied and does it require physical sterilization?

The software is supplied as a digital solution and does not require physical sterilization, as it is not a physical device. However, it must be installed on systems that comply with HIPAA regulations to ensure patient data security and confidentiality.

Can this software be used in existing imaging workflows, or does it require a separate system?

The BriefCase-Triage CARE Multi-Triage CT software is intended for use in radiology departments and can operate as either a standalone tool or be integrated into existing imaging workflows, depending on the hospital’s setup and IT infrastructure.

What regulatory approvals does the BriefCase-Triage CARE Multi-Triage CT software hold, and how does this affect its use?

The software holds FDA 510(k) clearance and MDR authorization, confirming it meets strict radiology-specific standards for diagnostic software. This ensures it adheres to regulatory requirements for safety and effectiveness in clinical settings, particularly in radiology departments.

Is the BriefCase-Triage CARE Multi-Triage CT software reusable or single-use, and how should it be stored?

Since the software is a digital solution, it is not reusable or single-use in the traditional sense. It requires proper installation on compliant, HIPAA-secure systems and should be maintained according to the manufacturer’s guidelines to ensure continued functionality and data integrity.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aidoc Medical Ltd
FDA Applicant
Aidoc Medical , Ltd.

Sources (2)

  • FDA 510(k) K253578 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026