September 14, 2016 — Medic Vision Imaging Solutions Ltd. announced last week that its vendor-independent, low-dose computed tomography (CT) solution was selected by Philips Healthcare to help meet XR-29 regulations.
Following a thorough qualification and verification process, Medic Vision’s U.S. Food and Drug Administration (FDA)-cleared SafeCT-29 product is now officially recommended by Philips as a solution for customers that have CT and positron emission tomography (PET)/CT scanners that are not fully compliant with XR-29 standards and for which Philips does not offer an XR-29 update. Philips tested SafeCT-29, evaluated its FDA 510(k) clearance and determined SafeCT-29 to be safe and effective.
SafeCT-29 is a patent-pending add-on system that provides full compliance with the XR-29 Dose Check and Dose Report (“RDSR”) functions for CT and PET/CT systems of all vendors and models. It is the only third-party XR-29 solution that is FDA-cleared.
According to the agreement between the companies, Philips sales and service personnel will now recommend Medic Vision’s SafeCT-29 to Philips customers with XR-29 noncompliant CT and PET/CT scanners. Integration of SafeCT-29 will not affect the Philips warranty, customer support agreement or its commitment to service the Philips scanners.
For more information: www.medicvision.com