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FDA 510(k)

Vista OS, Vista AI Scan, RTHawk

K-Number: K251029 · 2025-08-21

ApplicantVista AI, Inc.
Decision Date2025-08-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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