Regulatory Information

Our technical team works to the highest standard in the development of software and hardware for the Vision RT product range. In addition, quality procedures are in place for the manufacture and installation of the company’s medical products. We have received accreditation from the BSI for the internationally recognised ISO 13485:2016 quality system for medical devices.

Click here to read the Declaration of Conformity for AlignRT Plus, and here for SafeRT-ID.

The AlignRT, SafeRT-ID, GateCT and GateRT products have satisfied the various regulatory criteria below.

 

Europe

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

► Download EC certificate

SafeRT-ID is a Class I medical device.

 

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 Plus (including AlignRT, GateCT, GateRT and the frameless SRS module) 510(k) clearance letter

SafeRT-ID is listed with the FDA as a Class I medical device in the USA.

 

Australia

AlignRT, GateCT and GateRT are registered as Medical Devices Class IIb in the Australian Register of Therapeutic Goods.

SafeRT-ID is a Class I registered device in Australia.

 

Japan

Vision RT has received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) to market the AlignRT, GateCT and GateRT products in Japan.

► View PMDA cerficiate

 

Canada

Vision RT has received clearance from Health Canada to market AlignRT, GateCT and GateRT products as Class III medical devices in Canada.

► View Medical Device Licence / Homologation d’un instrument médical

SafeRT-ID is listed as a Class I device in Canada.