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ImageWorks

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ImageWorks is a medical device manufacturer, with 13 devices listed in FDA GUDID (FDA Class II) as of 13 Nov 2026.

Devices
13

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 13
Device classes
  • FDA Class II 13
Identifiers
  • DUNS 833648087

What ImageWorks makes

ImageWorks manufactures software applications for general-purpose dental X-ray systems, including intraoral digital imaging sensors and stationary intraoral digital X-ray systems. Their portfolio also includes mobile diagnostic X-ray system generators designed for dental use, alongside specialized software tools for image processing and analysis.

The company’s devices are classified under Class II regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, where the manufacturer is based.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

Newest first, rows 1-13 of 13

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  • Intraskan Dc 9992720200

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Evasoft 9992490800

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Intraskan Dc 9992720300

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Eva Select 9992412200

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Eva Select 9992412105

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Eva Select 9992412100

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Eva Select Direct 9992413100

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Eva Select Direct 9992413105

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Eva Select 9992412205

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Intraskan Dc 9992720100

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Intraskan Dc 9992720000

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Eva Select Direct 9992413205

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Eva Select Direct 9992413200

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

Rows 1-13 of 13

Company details

DUNS number
833648087

Frequently asked questions

How many devices does ImageWorks have in the registry?

The registry currently lists 13 devices for ImageWorks. Devices recorded under merged duplicate company entries are counted once.

Which registries list ImageWorks's devices?

Among its 13 most recently registered devices, ImageWorks has devices listed in FDA GUDID (13 devices).

What risk classes do ImageWorks's devices fall under?

Among its 13 most recently registered devices, the classes recorded for ImageWorks's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from ImageWorks in the registry?

The most recently registered devices listed for ImageWorks include INTRASKAN DC 9992720200, EVASOFT 9992490800, INTRASKAN DC 9992720300 and EVA SELECT 9992412200.

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