FDA 510(k)

Quicktome Software Suite

Número K: K261795 · 2026-09-10

RequerenteOmniscient Neurotechnology Pty, Ltd.

Data da decisão2026-09-10

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Quicktome Software Suite is the device name listed in this FDA 510(k) record. The listed applicant is Omniscient Neurotechnology Pty, Ltd.. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K261795. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Quicktome Software Suite?

Quicktome Software Suite is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Omniscient Neurotechnology Pty, Ltd.. The 510(k) number is K261795.

When did Quicktome Software Suite receive FDA 510(k) clearance?

Quicktome Software Suite received FDA 510(k) clearance on 2026-09-10, under 510(k) number K261795.

Quem é o solicitante listado para o Software Suite Quicktome?

The FDA 510(k) record lists Omniscient Neurotechnology Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quicktome Software Suite?

The FDA product code for Quicktome Software Suite is QIH.

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