Identifiers
- 510(k) Number
- K230856 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)
BrainSpec Core Software is a post-processing platform for Magnetic Resonance Spectroscopy (MRS) data, designed to analyze and interpret spectroscopic imaging results. It employs a linear combinations model to enhance the accuracy of MRS analysis, enabling clinicians and researchers to derive quantitative biochemical information from neuroimaging studies. The software is classified as a diagnostic radiology device, facilitating precise spectral analysis for clinical and research applications.
The software is supplied as a web-based platform, intended for use in clinical or research settings where MRS is performed. It is not described as single-use or reusable but is regulated under the FDA’s 510(k) clearance process, with a traditional review pathway. No details regarding sterility, MRI safety, or physical storage conditions are provided in the specifications. The device holds an FDA clearance (K230856) and is intended for use in radiology-related applications as determined by the Radiology Advisory Committee.
Frequently asked questions
What clinical or research applications is BrainSpec Core Software designed to support specifically?
BrainSpec Core Software is designed to analyze and interpret Magnetic Resonance Spectroscopy (MRS) data, providing quantitative biochemical information from neuroimaging studies. It uses a linear combinations model to improve the accuracy of spectral analysis, making it useful for clinical diagnostics and research where MRS is performed, particularly in radiology-related applications.
How is BrainSpec Core Software supplied, and where can it be used?
BrainSpec Core Software is supplied as a web-based platform, meaning it requires internet access and can be accessed from any location with a compatible device. It is intended for use in clinical or research settings where Magnetic Resonance Spectroscopy (MRS) is conducted, such as hospitals, research labs, or specialized imaging centers.
Is BrainSpec Core Software single-use or reusable, and what are its regulatory requirements?
BrainSpec Core Software is not described as single-use or reusable, as it is a digital platform rather than a physical device. It is regulated under the FDA’s 510(k) clearance process, specifically through a traditional review pathway, and holds an FDA clearance (K230856) for diagnostic radiology applications, as determined by the Radiology Advisory Committee.
What type of review pathway was used for the FDA clearance of BrainSpec Core Software?
BrainSpec Core Software underwent a traditional review pathway for its FDA clearance (K230856), which is the standard process for demonstrating substantial equivalence to a predicate device. The decision was made by the FDA’s Radiology Advisory Committee, confirming its classification as a diagnostic radiology device.
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: BrainSpec | Making the Virtual Biopsy a Reality, Company | BrainSpec, K230856 FDA 510(k) - BrainSpec Core Software | Brainspec, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230856 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainspec, Inc.
Sources (1)
- FDA 510(k) K230856 24 fields · synced Sep 20, 2026