GE files 510(k) for PET/MR system
Article Thumbnail ImageAugust 4, 2014 -- GE Healthcare has filed for 510(k) clearance of its new whole-body Signa PET/MR scanner with the U.S. Food and Drug Administration.

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The unit combines simultaneous image acquisition from GE's 3-tesla MR technology and PET, and it is designed to help physicians improve scan efficiency, particularly in oncology, neurology, and cardiology applications, GE said.

Signa PET/MR features GE's MR-compatible silicon photomultiplier detector (SiPM) technology, a digital detector that is up to three times more sensitive than conventional PET technology, according to the company. It also offers fast coincidence timing resolution to enable time-of-flight (TOF) reconstruction.

The Signa PET/MR system is fully upgradeable from GE's Discovery MR750w 3-tesla MRI unit, GE added.

GE has installed research systems at Stanford University; the University of California, San Francisco; and the University of Zurich.