EOS Imaging

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
17
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1415-2021Class IIThe EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated paDecember 22, 2020
Z-3188-2018Class IIsterEOS workstationAugust 1, 2018
Z-2626-2017Class IIROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue NumberMay 30, 2017
Z-1460-2015Class IIEOS, Digital radiography system used in general radiographic examinations.February 17, 2015
Z-0580-2014Class IIsteroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images November 29, 2013
Z-0529-2014Class IIEOS System X- ray beam Digital radiography system used in general radiographic examinations.November 7, 2013
Z-2072-2012Class IIEOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiogrJune 19, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K251078AutoDensityNovember 14, 2025
K251747VEA Align; spineEOSAugust 15, 2025
K233920EOSedgeAugust 6, 2024
K240582VEA Align; spineEOSJune 25, 2024
K231917VEA AlignJanuary 5, 2024
K232086spineEOSOctober 24, 2023
K202394EOSedgeSeptember 16, 2020
K192079EOSedgeNovember 27, 2019
K172346sterEOS WorkstationJune 19, 2018
K160914sterEOS WorkstationApril 22, 2016
K152788EOS SystemOctober 21, 2015
K142773EOS SystemJanuary 22, 2015
K141137STEREOS WORKSTATIONSeptember 15, 2014
K130395STEREOS WORKSTATIONMarch 11, 2013
K123740EOSFebruary 22, 2013
K113344STEREOS WORKSTATIONNovember 16, 2012
K120721EOSApril 6, 2012