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QBrain

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K050703

by Medis Medical Imaging Systems bv

Identifiers

510(k) Number
K050703 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The QBrain is a Computer-Aided Diagnosis (CAD) System for Radiology (Product Code: LLZ), designed to assist in the detection and analysis of intracranial abnormalities in computed tomography (CT) scans. It employs advanced image processing algorithms to enhance the visibility of calcifications, hemorrhages, and other intracranial pathologies, aiding radiologists in diagnostic accuracy and workflow efficiency.

Supplied as a software solution for use in radiology departments, the QBrain operates on standard medical imaging workstations and is intended for single-use per imaging session. It requires no sterilisation and is compatible with MRI environments when used in accordance with its software specifications. Authorised under FDA 510K clearance and MDD, the system adheres to regulatory standards for diagnostic imaging software, ensuring compliance with medical device legislation.

Frequently asked questions

What specific types of intracranial abnormalities does the QBrain help radiologists identify in CT scans?

The QBrain is designed to assist radiologists in detecting and analyzing intracranial calcifications and hemorrhages, as well as other intracranial pathologies. Its advanced image processing algorithms enhance visibility of these abnormalities to improve diagnostic accuracy during CT scan analysis.

How is the QBrain system supplied and what kind of workstation compatibility does it require?

The QBrain is supplied as a software solution intended for use in radiology departments. It operates on standard medical imaging workstations, meaning it does not require specialized hardware beyond what is commonly used for CT imaging analysis.

Is the QBrain system reusable or single-use, and does it require sterilization?

The QBrain is intended for single-use per imaging session, meaning it is not designed to be reused across multiple scans. Since it is a software solution, sterilization is not applicable, and no sterilization procedures are required.

What regulatory pathways has the QBrain undergone, and which advisory committee was involved?

The QBrain has been authorized through FDA 510K clearance and the Medical Device Directive (MDD). The FDA submission was reviewed by the Radiology (RA) Advisory Committee under the Traditional clearance type, with a decision code of SESE (Substantially Equivalent) in 2005.

Can the QBrain be used in an MRI environment, and if so, are there any specific considerations?

Yes, the QBrain is compatible with MRI environments when used in accordance with its software specifications. However, since it is a software-based solution, its operation in an MRI environment depends on the workstation’s compliance with MRI safety standards and the system’s own software guidelines.

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

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medis Medical Imaging Systems bv

Sources (2)

  • FDA 510(k) K050703 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026