FDA 510(k)

NeuroQuant PET

K-Number: K261916 · 2026-08-12

Decision Date2026-08-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NeuroQuant PET is the device name listed in this FDA 510(k) record. The listed applicant is Cortechs Labs, Inc.. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K261916. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroQuant PET?

NeuroQuant PET is a medical device that received FDA 510(k) clearance on 2026-08-12. The listed applicant is Cortechs Labs, Inc.. The 510(k) number is K261916.

When did NeuroQuant PET receive FDA 510(k) clearance?

NeuroQuant PET received FDA 510(k) clearance on 2026-08-12, under 510(k) number K261916.

Who is the listed applicant for NeuroQuant PET?

The FDA 510(k) record lists Cortechs Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroQuant PET?

The FDA product code for NeuroQuant PET is LLZ.

Other records listing Cortechs Labs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241098NeuroQuant K210831OnQ Neuro K170981NeuroQuant

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Official Source

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