Qfix

FDA Regulatory Profile

Qfix has 0 FDA recalls, 0 inspections, 7 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Mar 31, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances7Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K230312Iris AirShuttle™Mar 31, 2023
K193243Alta Multipurpose DeviceFeb 28, 2020
K190668Encompass 15 Channel Head Coil, 3TSep 9, 2019
K182189Encompass SRS Headframe ; Encompass MR SRS HeadframeOct 4, 2018
K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesJul 11, 2017
K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface…Jun 14, 2016
K152321kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass…Dec 4, 2015