Vision RT works towards high standards and operates in accordance with the ISO 13485:2003 quality system.

Vision RT's products are regulated for the following markets:

Europe

AlignRT®, GateCT® and GateRT® are approved as class IIb medical devices.

 Download EC certificate


USA

Vision RT has received 510(k) clearance from the FDA to market the AlignRT®, GateCT® and GateRT® products as class II medical devices in the USA.

 Download AlignRT 510(k) clearance letter

 Download GateCT-RT 510(k) clearance letter

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