FDA 510(k)

Neurophet AQUA (V3.1)

K-Number: K242215 · 2024-10-25

Decision Date2024-10-25

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Neurophet AQUA (V3.1) is a medical device manufactured by Neurophet., Inc.. It received FDA 510(k) clearance on 2024-10-25 under approval number K242215. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurophet AQUA (V3.1)?

Neurophet AQUA (V3.1) is a medical device that received FDA 510(k) clearance on 2024-10-25. It is manufactured by Neurophet., Inc.. The 510(k) number is K242215.

When was Neurophet AQUA (V3.1) approved by the FDA?

Neurophet AQUA (V3.1) received FDA 510(k) clearance on 2024-10-25, under approval number K242215.

What company makes Neurophet AQUA (V3.1)?

Neurophet AQUA (V3.1) is manufactured by Neurophet., Inc..

What is the FDA product code for Neurophet AQUA (V3.1)?

The FDA product code for Neurophet AQUA (V3.1) is QIH.

Other Devices by Neurophet., Inc.

K221405Neurophet SCALE PET K220437Neurophet AQUA K252563Neurophet SCALE PET K261273Neurophet AQUA K252496Neurophet AQUA AD Plus

Related Devices (Code: QIH)

K191647QLAB Advanced Quantification SoftwarePhilips Health Care K191171EchoGo CoreUltromics, Ltd. K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. K202546LVivo SeamlessDia Imaging Analysis, Ltd. K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.