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Carestream Heatlh, Inc.

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Devices
1

What Carestream Heatlh, Inc. makes

Carestream Health, Inc. develops and provides the CARESTREAM IMAGE SUITE, a software platform designed for medical imaging workflows, including picture archiving and communication systems (PACS) and radiology information systems (RIS).

The company’s portfolio is regulated under FDA Class II devices and is listed via 510(k) clearance. The manufacturer is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Carestream Image Suite Ref K100094

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

Frequently asked questions

How many devices does Carestream Heatlh, Inc. have in the registry?

The registry currently lists 1 device for Carestream Heatlh, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Carestream Heatlh, Inc.'s devices?

Among its 1 most recently registered device, Carestream Heatlh, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Carestream Heatlh, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Carestream Heatlh, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Carestream Heatlh, Inc. in the registry?

The most recently registered devices listed for Carestream Heatlh, Inc. include CARESTREAM IMAGE SUITE.

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