Identifiers
- 510(k) Number
- K220815 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 a device classified under the Radiology advisory committee. It received a traditional 510(k) clearance as substantially equivalent to a predicate device.
The device was manufactured by Hyperfine, Inc. and cleared under K220815. It is authorized for distribution in the United States with FDA 510(k) clearance.
Frequently asked questions
What is the BrainInsight device used for?
BrainInsight is classified under the Radiology advisory committee and received traditional 510(k) clearance as substantially equivalent to a predicate device, indicating its intended use aligns with radiology applications as defined by its regulatory classification.
Who manufactures the BrainInsight device and what is its clearance number?
The BrainInsight device is manufactured by Hyperfine, Inc. and was cleared under the traditional 510(k) pathway with clearance number K220815, as specified in the device's authorization records.
What regulatory pathway was used for BrainInsight's authorization?
BrainInsight received a traditional 510(k) clearance, meaning it was found substantially equivalent to a legally marketed predicate device, which is the standard pathway for moderate-risk medical devices in the U.S.
Is BrainInsight authorized for distribution in the United States?
Yes, BrainInsight is authorized for distribution in the United States, as explicitly stated in the device data, which notes its FDA 510(k) clearance and U.S. distribution authorization.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220815 | Class II | Active |
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Manufacturer
- Manufacturer
- Hyperfine, Inc.
Sources (1)
- FDA 510(k) K220815 24 fields · synced Sep 23, 2026