FDA 510(k)

Artificial Intelligence Renal Assessment (AIRA) Version 1

Numéro K : K261677 · 2026-09-15

DemandeurAramis Global AI Consultancies, LLC

Date de décision2026-09-15

Code produitQIH

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Artificial Intelligence Renal Assessment (AIRA) Version 1 is the device name listed in this FDA 510(k) record. The listed applicant is Aramis Global AI Consultancies, LLC. It received FDA 510(k) clearance on 2026-09-15 under 510(k) number K261677. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Artificial Intelligence Renal Assessment (AIRA) Version 1?

Artificial Intelligence Renal Assessment (AIRA) Version 1 is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Aramis Global AI Consultancies, LLC. The 510(k) number is K261677.

When did Artificial Intelligence Renal Assessment (AIRA) Version 1 receive FDA 510(k) clearance?

Artificial Intelligence Renal Assessment (AIRA) Version 1 received FDA 510(k) clearance on 2026-09-15, under 510(k) number K261677.

Who is the listed applicant for Artificial Intelligence Renal Assessment (AIRA) Version 1?

The FDA 510(k) record lists Aramis Global AI Consultancies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artificial Intelligence Renal Assessment (AIRA) Version 1?

The FDA product code for Artificial Intelligence Renal Assessment (AIRA) Version 1 is QIH.

Essais cliniques associés

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Source officielle

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