FDA gives green light for Nucletron's Oncentra VISIR 2.0
Nucletron B.V. has received U.S. Food and Drug Administration 510k clearance for its Oncentra VISIR 2.0 record and verify system.
Features of the FDA-approved system include an audit trail of all changes to patient data, support for dynamic MLC IMRT (intensity modulated radiation therapy) delivery, orthogonal mode for imaging and the unique ability to schedule portal images by protocol.
The company said the system features an image-based verification module that improves accuracy by automatically comparing portal images to a reference image and determining patient displacement. A trend analysis of these positioning variances can be performed and a net adjustment can be made. The corrective action is submitted directly into the record and verify system for the patient's next treatment.
Features of the FDA-approved system include an audit trail of all changes to patient data, support for dynamic MLC IMRT (intensity modulated radiation therapy) delivery, orthogonal mode for imaging and the unique ability to schedule portal images by protocol.
The company said the system features an image-based verification module that improves accuracy by automatically comparing portal images to a reference image and determining patient displacement. A trend analysis of these positioning variances can be performed and a net adjustment can be made. The corrective action is submitted directly into the record and verify system for the patient's next treatment.