Neurophet AQUA AD Plus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252496 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 AD Plus is a contrast agent designed for use in magnetic resonance imaging (MRI) procedures. It is classified as a diagnostic radiopharmaceutical agent, specifically intended for enhancing the visibility of vascular structures and tissues during MRI scans.
This device is supplied as a sterile, single-use solution and is regulated under FDA 510(k) clearance and the European Medical Device Directive (MDD). It is intended for use in MRI-compatible settings and must be handled according to standard radiopharmaceutical protocols. The product is authorized under the product code QIH and is distributed by Neurophet Inc., Seoul, South Korea.
Frequently asked questions
What types of MRI procedures is the Neurophet AQUA AD Plus intended to enhance, and how does it improve visibility during scans?
The Neurophet AQUA AD Plus is specifically designed as a contrast agent to enhance the visibility of vascular structures and tissues during MRI procedures. By improving contrast resolution, it helps clinicians better visualize blood vessels and soft tissues, which can be particularly useful in identifying abnormalities like tumors, vascular malformations, or inflammatory conditions.
Is the Neurophet AQUA AD Plus meant for repeated use in the same patient, or is it a single-use product?
The Neurophet AQUA AD Plus is supplied as a sterile, single-use solution, meaning each vial is intended for one administration per patient. This ensures safety and compliance with radiopharmaceutical handling protocols, preventing contamination or degradation between uses.
How should the Neurophet AQUA AD Plus be stored, and are there any special handling requirements?
While the exact storage conditions aren’t detailed in the provided data, as a sterile diagnostic radiopharmaceutical, it should be stored according to standard radiopharmaceutical protocols—typically refrigerated (2–8°C) and protected from light until use. Always follow the manufacturer’s instructions or accompanying documentation for precise storage guidelines to maintain efficacy and sterility.
What regulatory pathways does the Neurophet AQUA AD Plus follow, and which committees or directives govern its use?
The device is regulated under FDA 510(k) clearance (K252496) and the European Medical Device Directive (MDD). Its classification as a diagnostic radiopharmaceutical was reviewed by the FDA’s Radiology (RA) Advisory Committee, with a decision of *Substantially Equivalent* (SESE) under the product code QIH. This means it meets established safety and performance standards for MRI contrast agents.
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 | K252496 | Class II | Active |
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Manufacturer
- Manufacturer
- NEUROPHET Inc.
- FDA Applicant
- Neurophet., Inc.
Sources (2)
- FDA 510(k) K252496 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026