FDA 510(k)

NeuroQuant

K-Number: K170981 · 2017-09-07

Decision Date2017-09-07

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NeuroQuant 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 2017-09-07 under 510(k) number K170981. 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?

NeuroQuant is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Cortechs Labs, Inc.. The 510(k) number is K170981.

When did NeuroQuant receive FDA 510(k) clearance?

NeuroQuant received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170981.

Who is the listed applicant for NeuroQuant?

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?

The FDA product code for NeuroQuant 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.

K261916NeuroQuant PET K241098NeuroQuant K210831OnQ Neuro

Related Devices (Code: LLZ)

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, 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.