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FDA 510(k)

BrainSpec Core™ Software

K-Number: K230856 · 2023-11-14

ApplicantBrainspec, Inc.
Decision Date2023-11-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BrainSpec Core™ Software is the device name listed in this FDA 510(k) record. The listed applicant is Brainspec, Inc.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K230856. 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 BrainSpec Core™ Software?

BrainSpec Core™ Software is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Brainspec, Inc.. The 510(k) number is K230856.

When did BrainSpec Core™ Software receive FDA 510(k) clearance?

BrainSpec Core™ Software received FDA 510(k) clearance on 2023-11-14, under 510(k) number K230856.

Who is the listed applicant for BrainSpec Core™ Software?

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

What is the FDA product code for BrainSpec Core™ Software?

The FDA product code for BrainSpec Core™ Software is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid 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.

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