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NeuroQuant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241098

by Cortechs Labs Inc

Identifiers

510(k) Number
K241098 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)

NeuroQuant is a fully automated advanced imaging software classified as a Computer-Assisted Diagnosis Product (U.S. FDA nomenclature) for brain MRI segmentation and volumetric quantification. It provides objective, quantitative measurements of brain structure volumes, supporting the detection and monitoring of neurological conditions through AI-driven analysis of MRI scans.

This device is supplied as a software application for use in clinical radiology settings, requiring MRI-compatible hardware for operation. It is intended for single-use per imaging session, with no sterility requirements, and operates under FDA 510(k) clearance (K241098) as substantially equivalent to a predicate device. No specific size or storage conditions are noted beyond standard IT infrastructure requirements for medical imaging software.

Frequently asked questions

What types of neurological conditions can NeuroQuant help detect or monitor through MRI scans?

NeuroQuant is designed to provide objective, quantitative measurements of brain structure volumes by analyzing MRI scans using AI-driven technology. While it supports the detection and monitoring of neurological conditions, the specific conditions it aids in identifying are not detailed in the provided data. It is primarily used in clinical radiology settings to assist in assessing brain anatomy through volumetric quantification, which can be relevant for conditions affecting brain structures like Alzheimer’s, multiple sclerosis, or other neurodegenerative diseases.

How is NeuroQuant supplied, and what are the requirements for its use in a clinical setting?

NeuroQuant is supplied as a software application that runs on MRI-compatible hardware within clinical radiology settings. It is intended for single-use per imaging session, meaning it is not reusable or sterilized. The software does not have specific sterility requirements, but it must be installed and operated on standard IT infrastructure compatible with medical imaging systems. No physical hardware or consumables are required beyond the MRI machine and the necessary computing environment.

What regulatory pathway was followed for NeuroQuant’s FDA clearance, and who is the applicant?

NeuroQuant received FDA clearance through a 510(k) premarket notification process, specifically under the Traditional Review pathway with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). The applicant for this clearance was Cortechs Labs, Inc., based in San Diego, CA. The device was reviewed by the Radiology (RA) Advisory Committee and classified under product code QIH, indicating its classification as a Computer-Assisted Diagnosis Product.

Is NeuroQuant compatible with all MRI machines, or are there specific hardware requirements?

The provided data does not specify compatibility with particular MRI machine models, but NeuroQuant is explicitly designed to operate on MRI-compatible hardware within clinical radiology settings. For accurate use, the software must be installed on systems that meet standard IT infrastructure requirements for medical imaging software. Users should verify compatibility with their existing MRI equipment and consult the manufacturer’s guidelines for optimal performance.

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: NeuroQuant - Cortechs.ai, Home - Cortechs.ai, NeuroQuant - Physician AI Tools, PDF CorTechs Labs, Inc. August 22, 2024

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cortechs Labs Inc
FDA Applicant
Cortechs Labs, Inc.

Sources (1)

  • FDA 510(k) K241098 24 fields · synced Sep 19, 2026