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Soredex Palodex Group Oy

FinlandFDA applicant, unverified

Devices
9

What Soredex Palodex Group Oy makes

The company manufactures intraoral and extraoral dental X-ray systems, including digital sensors and panoramic imaging devices for intraoral and cone-beam computed tomography (CBCT) applications. Products include intraoral digital sensors (e.g., MINRAY), panoramic X-ray machines (e.g., CRANEX NOVUS, CRANEX BASEX D), and 3D imaging systems (e.g., SCANORA 3D, CRANEX D). Additional offerings include digital panoramic units with integrated software (e.g., DIGORA PCT/DIGIPOD) and intraoral sensors with enhanced imaging modes (e.g., DIGORA OPTIME).

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The company is based in the United States.

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

Catalogue9

Newest first, rows 1-9 of 9

  • Scanora 3D Ref K110839

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

  • Digora Pct Ref K012170

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

  • Minray Ref K033755

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

  • Scanora 3D Ref K073350

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

  • Digora Pct/Digipod Ref K070304

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

  • Cranex Basex D Or Cranex Excel D Ref K040382

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

  • Cranex Novus Ref K063459

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

  • Digora Optime (Or Digora Ontime) Ref K041050

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

  • Cranex D Ref K043307

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

Frequently asked questions

How many devices does Soredex Palodex Group OY have in the registry?

The registry currently lists 9 devices for Soredex Palodex Group OY. Devices recorded under merged duplicate company entries are counted once.

Which registries list Soredex Palodex Group OY's devices?

Among its 9 most recently registered devices, Soredex Palodex Group OY has devices listed in FDA 510(k) (9 devices).

What risk classes do Soredex Palodex Group OY's devices fall under?

Among its 9 most recently registered devices, the classes recorded for Soredex Palodex Group OY's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Soredex Palodex Group OY in the registry?

The most recently registered devices listed for Soredex Palodex Group OY include SCANORA 3D, DIGORA PCT, MINRAY and DIGORA PCT/DIGIPOD.

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