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.
The AlignRT, SafeRT-ID, GateCT and GateRT products have satisfied the various regulatory criteria below.
AlignRT, GateCT and GateRT are approved as Class IIb medical devices.
SafeRT-ID is a Class I medical device.
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.
SafeRT-ID is listed with the FDA as a Class I medical device in the USA.
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.
Vision RT has received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) to market the AlignRT, GateCT and GateRT products in Japan.
Vision RT has received clearance from Health Canada to market AlignRT, GateCT and GateRT products as Class III medical devices in Canada.
SafeRT-ID is listed as a Class I device in Canada.