Neurophet AQUA (V3.1)

FDA 510(k) K242215 · Neurophet., Inc.

Substantially Equivalent

510(k) numberK242215

Submission

Device name
Neurophet AQUA (V3.1)
Applicant
Neurophet., Inc.
Seoul, KR
Received
July 29, 2024
Decision date
October 25, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QIH – Automated Radiological Image Processing Software
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Other 510(k)s with product code QIH

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K261795Quicktome Software SuiteQIH · Traditional Omniscient Neurotechnology Pty, Ltd.09/10/2026SE
K2608794DMQIH · Traditional Invia, LLC09/10/2026SE
K251417ReVISION 2QIH · Traditional Argus Cognitive, Inc.09/09/2026SE
K260525NextMR SpineQIH · Traditional MRI2CT, Inc.09/04/2026SE
K260811Heartvue.ProtonQIH · Traditional Heartvue.ai, Inc.08/26/2026SE
K261595Ceevra Reveal 4QIH · Traditional Ceevra, Inc.08/25/2026SE
K262127DS Core CBCT AnatomyQIH · Traditional Dentsply Sirona08/21/2026SE
K260584BoneMRIQIH · Traditional Mriguidance B.V.08/21/2026SE
K261641Lower Limb AI (LLAI)QIH · Traditional AI Planning Logic, Inc.08/18/2026SE
K253794Prostate CoreQIH · Traditional Lucida Medical, Ltd.08/10/2026SE

More from Lucida Medical, Ltd.

510(k)DeviceDecision
K261273Neurophet AQUAQIH · Special 05/15/2026SE
K252563Neurophet SCALE PETQIH · Traditional 05/15/2026SE
K252496Neurophet AQUA AD PlusQIH · Traditional 01/29/2026SE
K220437Neurophet AQUALLZ · Traditional 05/10/2023SE
K221405Neurophet SCALE PETLLZ · Traditional 08/05/2022SE

Questions and answers

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

Neurophet AQUA (V3.1) (K242215) received a 510(k) decision of Substantially Equivalent on October 25, 2024, 88 days after the submission was received.

What is the product code of K242215?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.