FDA Grants 510(k) Clearance to Qfix for Encompass SRS Immobilization System

December 7, 2015

The FDA has awarded radiotherapy devicemaker Qfix 510(k) clearance for its Encompass SRS Immobilization System for stereotactic radiosurgery.

The device is cleared for sub-millimeter immobilization to treat multiple lesions with a single isocenter.

The system uses a posterior thermoplastic and anterior open view mask compatible with optical tracking systems. It also features an optional IntegraBite, which can be used to further reduce motion to enable maximum dose to the tumor while minimizing radiation delivery to surrounding healthy tissue.

The device is currently used for intracranial radiotherapy treatments. — Michael Cipriano