FDA 510(k) Applications Submitted by Qfix

FDA 510(k) Number Submission Date Device Name Applicant
K190668 03/15/2019 Encompass 15 Channel Head Coil, 3T Qfix
K182189 08/13/2018 Encompass SRS Headframe ; Encompass MR SRS Headframe Qfix
K193243 11/25/2019 Alta Multipurpose Device Qfix
K171133 04/17/2017 Qfix« Abdominal/Thoracic Motion Control System,Qfix« SBRT Solution and Accessories Qfix
K230312 02/03/2023 Iris AirShuttleÖ Qfix
K160627 03/07/2016 Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution QFIX
K152321 08/17/2015 kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fi QFIX


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