FDA 510(k)

Vista OS, Vista AI Scan, RTHawk

Número K: K251029 · 2025-08-21

Data da decisão2025-08-21

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vista OS, Vista AI Scan, RTHawk is the device name listed in this FDA 510(k) record. The listed applicant is Vista AI, Inc.. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K251029. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vista OS, Vista AI Scan, RTHawk?

Vista OS, Vista AI Scan, RTHawk is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Vista AI, Inc.. The 510(k) number is K251029.

When did Vista OS, Vista AI Scan, RTHawk receive FDA 510(k) clearance?

Vista OS, Vista AI Scan, RTHawk received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251029.

Who is the listed applicant for Vista OS, Vista AI Scan, RTHawk?

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

What is the FDA product code for Vista OS, Vista AI Scan, RTHawk?

The FDA product code for Vista OS, Vista AI Scan, RTHawk is LNH.

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