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Sign in to claim this brandBrainreader Aps
US
Last updated May 27, 2026
What Brainreader Aps makes
Brainreader Aps develops software applications focused on image segmentation for medical imaging, specifically designed for neurological analysis. Their primary product, Neuroreader, specializes in processing and interpreting brain scans to assist in diagnostic workflows, including automated segmentation of neuroanatomical structures.
The company’s portfolio is regulated under Class II medical devices in the United States, with authorisations granted through FDA pathways including 510(k) submissions and the Unique Device Identifier (UDI) system. Their products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Brainreader Aps manufacture?
Brainreader Aps specializes in developing image segmentation application software for medical imaging. Their primary focus is on neurological analysis, with their main product, Neuroreader, designed to process and interpret brain scans. This software automates the segmentation of neuroanatomical structures to support diagnostic workflows.
Where is Brainreader Aps based, and how does this affect its regulatory compliance?
Brainreader Aps is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations. The company’s products fall under Class II classification, which requires compliance with FDA pathways like 510(k) submissions and the Unique Device Identifier (UDI) system to ensure regulatory authorisation.
Which regulatory registries list Brainreader Aps’s devices?
Brainreader Aps’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) clearance pathway and the Unique Device Identifier (UDI) system. These registries confirm compliance with U.S. medical device regulations for their image segmentation software, such as Neuroreader.
How are Brainreader Aps’s devices classified under U.S. regulations?
Brainreader Aps’s devices are classified as Class II medical devices in the United States. This classification is determined by the FDA based on the level of risk associated with the product. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, which is why they must go through pathways like 510(k) submissions for regulatory authorisation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- brainreader.net
- —
- —
- [email protected]
- Phone
- +4553524749
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 305279427
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Neuroreader | 2.4 | FDA UDI | Class II | Unknown |
| Neuroreader | 2.6 | FDA UDI | Class II | Active |
| Neuroreader | 2.2.8 | FDA UDI | Class II | Unknown |
| Neuroreader | 2.5 | FDA UDI | Class II | Unknown |
| Neuroreader | 2.2.9 | FDA UDI | Class II | Unknown |
| Neuroreader | 2.7 | FDA UDI | Class II | Active |
| Neuroreader | 2.3 | FDA UDI | Class II | Unknown |
| Neuroreader Medical Image Processing Software | K140828 | FDA 510(k) | Class II | Active |
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