FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Qfix Receives FDA Clearance for Diagnostic Imaging Coil

Sept. 16, 2019
A A

Qfix was granted 510(k) clearance for its Encompass 15-channel head coil, a diagnostic imaging device used with its immobilization device and specific MRI scanners.

The device provides diagnostic quality images for select Siemens 3T MRI scanners and is optimized for use with Qfix’s Encompass stereotactic radiosurgery (SRS) MRI immobilization system, a device used to reduce patient movement during radiosurger treatments.

MR images obtained with the immobilization system can be used for SRS treatment planning, including MR only and MR/ultrasound fusion-guided techniques.

View today's stories