Identifiers
- 510(k) Number
- K223268 FDA 510(k)
- FDA Product Code
- QIH 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)
BrainInsight is an AI-powered software device designed for automated post-processing of magnetic resonance imaging (MRI) brain scans. It leverages machine learning to analyze ultra-low-field MRI images, enabling the labeling, segmentation, and measurement of brain structures. The system provides clinicians with annotated images, color overlays, and structured reports to assist in evaluating brain anatomy and pathology. This tool is classified under the FDA’s Radiology category and is intended for use in acute and critical care settings.
BrainInsight is supplied as a cloud-based software solution and integrates with FDA-cleared Picture Archiving and Communication Systems (PACS). It is intended for single-use per imaging session, though the underlying software platform may support multiple deployments. The device operates in environments such as emergency departments and intensive care units, where rapid diagnostic insights are critical. Authorized under FDA 510(k) clearance (K223268), it adheres to regulatory standards for AI-driven medical imaging software.
Frequently asked questions
How does BrainInsight integrate with existing medical imaging workflows and what systems does it work with?
BrainInsight is designed as a cloud-based software solution that integrates directly with FDA-cleared Picture Archiving and Communication Systems (PACS). This integration allows clinicians to upload ultra-low-field MRI brain scans for automated post-processing, enabling the software to generate labeled, segmented images and structured reports without requiring additional hardware. The cloud-based approach ensures accessibility across acute and critical care settings like emergency departments and intensive care units, where rapid diagnostic insights are essential.
Is BrainInsight intended for repeated use across multiple patients, or is it meant to be used once per imaging session?
BrainInsight is specified for single-use per imaging session, meaning it processes one MRI scan at a time for a specific patient. However, the underlying software platform itself supports multiple deployments, allowing healthcare facilities to utilize the system for sequential patients or imaging sessions as needed. This distinction ensures clarity on usage per session while acknowledging the broader scalability of the platform.
What types of environments is BrainInsight optimized for, and why?
BrainInsight is explicitly optimized for acute and critical care settings, such as emergency departments and intensive care units. These environments prioritize rapid diagnostic insights, and the software’s automated post-processing of ultra-low-field MRI scans—including labeling, segmentation, and measurement of brain structures—is tailored to support time-sensitive clinical decisions. The cloud-based nature further enhances accessibility in fast-paced settings where immediate analysis is critical.
Does BrainInsight require any specific hardware or additional devices to function, or is it purely software-based?
BrainInsight is a purely software-based solution and does not require additional hardware beyond the MRI scanner used to capture the initial ultra-low-field brain images. It relies on integration with FDA-cleared Picture Archiving and Communication Systems (PACS) to upload and process scans, ensuring compatibility with existing infrastructure. The cloud-based deployment eliminates the need for on-site hardware installations, simplifying integration into clinical workflows.
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: BrainInsight Review: Pricing, FDA Status & Alternatives | Physician AI ..., BrainInsight | FDA Radiology AI Device, K202414 FDA 510(k) - BrainInsight | Hyperfine Research, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223268 | Class II | Active |
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Manufacturer
- Manufacturer
- Hyperfine, Inc.
Sources (1)
- FDA 510(k) K223268 24 fields · synced Sep 20, 2026