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Vista AI, Inc.

United StatesFDA applicant, unverified

Devices
2

What Vista AI, Inc. makes

Vista AI, Inc. develops medical imaging software solutions, including a core operating system (Vista OS) for radiology workflows, a scanning application (Vista AI Scan) for AI-assisted image acquisition, and a real-time diagnostic tool (RTHawk) for detecting acute conditions in imaging studies.

The company’s portfolio consists of Class II devices authorised via the FDA’s 510(k) pathway and is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Vista AI Scan Ref K260092

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Vista OS, Vista AI Scan, RTHawk Ref K251029

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Vista AI, Inc. have in the registry?

The registry currently lists 2 devices for Vista AI, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Vista AI, Inc.'s devices?

Among its 2 most recently registered devices, Vista AI, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Vista AI, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Vista AI, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Vista AI, Inc. in the registry?

The most recently registered devices listed for Vista AI, Inc. include Vista AI Scan and Vista OS, Vista AI Scan, RTHawk.

Generated automatically from registry data and not verified by a human reviewer.