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Home / Why FIDEX / Regulatory & radiation protection
Regulatory & radiation protection

What installing a CT means for your practice, legally and practically.

Every FIDEX installation sits inside a national radiation-protection framework. This page sets out the steps involved, who is responsible for each, and how Animage and your distributor support them.

Device status

CE marking and conformity

FIDEX systems are CE-marked for the European market. The declaration of conformity, the applicable directives and the notified-body reference are supplied with each system and available on request before purchase.

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Before, during and after installation

Six steps, and who owns each

Terminology and authorities differ by country. The sequence does not. France is shown as the worked example; your distributor maps it to your jurisdiction.

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Room layout and shielding

Designed for a normal room, assessed for yours

Cone-beam CT scatters less than conventional CT and FIDEX needs no dedicated suite. Shielding is still assessed per site by the radiation-protection expert, based on room dimensions, adjacent occupancy and expected workload.

Minimum room area, wall shielding guidance and controlled-area dimensions to be supplied from the installation specification.
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After go-live

Periodic testing and ongoing obligations

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Get a site-specific regulatory checklist

Tell us your country and room, and your distributor returns the steps, forms and typical timeline for your jurisdiction.

Request the Checklist Find Your Distributor