Identifiers
- 510(k) Number
- K242215 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)
The Neurophet AQUA (V3.1) is a medical imaging device classified under the product code QIH, intended for use in radiology procedures. It is designed to assist in the visualization and analysis of neurological structures, aiding in diagnostic evaluations for conditions affecting the brain and nervous system.
This device is supplied by Neurophet Inc. and is cleared under the FDA 510(k) pathway as substantially equivalent to a predicate device, with an authorization date of October 25, 2024. It is intended for single-use or reusable applications in clinical settings, adhering to the Medical Device Directive (MDD) standards. The device is not explicitly noted as MRI-safe or unsafe, and its storage and handling instructions are not specified in the provided data.
Frequently asked questions
What clinical area is the Neurophet AQUA (V3.1) primarily used in, and how does it assist clinicians?
The Neurophet AQUA (V3.1) is designed for use in radiology procedures, specifically to aid in the visualization and analysis of neurological structures. It supports diagnostic evaluations for conditions affecting the brain and nervous system by enhancing imaging clarity and analysis capabilities, helping clinicians better assess neurological health.
Is the Neurophet AQUA (V3.1) intended for single-use or reusable applications, and what does this mean for clinical workflows?
The device is explicitly noted as suitable for *either* single-use or reusable applications in clinical settings. This flexibility allows facilities to choose based on their infection control protocols, resource availability, and operational needs, ensuring compatibility with various workflows while adhering to regulatory standards like the Medical Device Directive (MDD).
How was the Neurophet AQUA (V3.1) approved by the FDA, and what does this mean for its regulatory status?
The device was cleared under the FDA’s 510(k) pathway as *substantially equivalent* to a predicate device, with a clearance date of October 25, 2024. This means the FDA determined it poses the same risks and benefits as an existing, legally marketed device in the same category (product code QIH, Radiology), ensuring it meets regulatory requirements for safety and effectiveness without requiring a full de novo review.
What does the product code QIH indicate about the intended use or classification of the Neurophet AQUA (V3.1)?
The product code QIH classifies the Neurophet AQUA (V3.1) under the FDA’s radiology category, specifically for devices used in imaging and diagnostic evaluations. This classification reflects its role in enhancing neurological imaging—such as MRI or CT scans—rather than therapeutic or surgical applications, aligning it with other imaging adjuncts in the same regulatory pathway.
Are there any specific storage or handling instructions provided for the Neurophet AQUA (V3.1), or should facilities follow general medical device guidelines?
The provided data does not specify storage or handling instructions for the Neurophet AQUA (V3.1). Facilities should refer to the manufacturer’s instructions (available from Neurophet Inc.) or follow standard medical device protocols to ensure proper maintenance, sterility (if applicable), and environmental conditions, particularly if the device is reused. Always verify compatibility with your facility’s infection control policies.
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 (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242215 | Class II | Active |
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Manufacturer
- Manufacturer
- NEUROPHET Inc.
- FDA Applicant
- Neurophet., Inc.
Sources (2)
- FDA 510(k) K242215 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026