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Owandy Radiology

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Owandy Radiology is a medical device manufacturer, with 37 devices listed in FDA GUDID (FDA Class II) as of 14 Nov 2026.

Devices
37

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 37
Device classes
  • FDA Class II 37
Sites and related companies
Identifiers
  • DUNS 265612235

What Owandy Radiology makes

Owandy Radiology manufactures digital dental X-ray systems, including stationary intraoral and panoramic/tomographic units, as well as intraoral digital imaging sensors and phosphor storage cassettes for dental use. Their portfolio includes mobile intraoral X-ray systems designed for flexible clinical applications.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue37

Newest first, rows 1-37 of 37

Search and filter all 37 devices
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  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX PRO

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX PRO CORE KIT SC NO BRACKET

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology Opteo

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology Opteo

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology ONE #2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology ONE #1

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology Ow-RX

    Withdrawn Registry: GUDID Class:II
  • I-Max Pan Only Floor 100-120V

    Active Regimes: 510(k) Registry: GUDID Class:II
  • I-Max Pan Ceph Double Sensor 110-120V

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX PRO

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • I-Max 3D Pan Only Floor 100-120V

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX PRO

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • I-Max Pan Ceph 110-120V

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology OWANDY OPTEO SIZE 1.5

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology I-Max Touch

    Withdrawn Registry: GUDID Class:II
  • I-Max 3D Pan Ceph 110-120V

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC DC OWANDY 115V, SHORT CONE, MOBILE

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology I-Max 3D

    Listed Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology I-Max

    Listed Registry: GUDID Class:II
  • Owandy Radiology I-Max Touch 3D

    Withdrawn Registry: GUDID Class:II
  • Owandy Radiology Owandy-CR

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy Radiology Owandy-CR

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Owandy-RX DC DC OWANDY 115V VET, SHORT CONE, MOBILE

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

Rows 1-37 of 37

Company details

DUNS number
265612235

Sites1

Frequently asked questions

How many devices does OWANDY RADIOLOGY have in the registry?

The registry currently lists 37 devices for OWANDY RADIOLOGY. Devices recorded under merged duplicate company entries are counted once.

Which registries list OWANDY RADIOLOGY's devices?

Among its 37 most recently registered devices, OWANDY RADIOLOGY has devices listed in FDA GUDID (37 devices).

What risk classes do OWANDY RADIOLOGY's devices fall under?

Among its 37 most recently registered devices, the classes recorded for OWANDY RADIOLOGY's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from OWANDY RADIOLOGY in the registry?

The most recently registered devices listed for OWANDY RADIOLOGY include Owandy-RX DC, Owandy-RX PRO, Owandy-RX PRO CORE KIT SC NO BRACKET and Owandy Radiology Opteo.

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