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FDA 510(k)

KBA3D (v2.4.0)

K-Number: K261500 · 2026-08-17

ApplicantS.M.A.I.O
Decision Date2026-08-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KBA3D (v2.4.0) is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2026-08-17 under 510(k) number K261500. 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 KBA3D (v2.4.0)?

KBA3D (v2.4.0) is a medical device that received FDA 510(k) clearance on 2026-08-17. The listed applicant is S.M.A.I.O. The 510(k) number is K261500.

When did KBA3D (v2.4.0) receive FDA 510(k) clearance?

KBA3D (v2.4.0) received FDA 510(k) clearance on 2026-08-17, under 510(k) number K261500.

Who is the listed applicant for KBA3D (v2.4.0)?

The FDA 510(k) record lists S.M.A.I.O as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KBA3D (v2.4.0)?

The FDA product code for KBA3D (v2.4.0) is LLZ.

Other records listing S.M.A.I.O as applicant

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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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