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EOS IMAGING

France·FR-MF-000000502

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Stereos Workstation	K141137	FDA 510(k)	Class II	Active
sterEOS Workstation	K172346	FDA 510(k)	Class II	Active
VEA Align; spineEOS	K251747	FDA 510(k)	Class II	Active
Stereos Workstation	K113344	FDA 510(k)	Class II	Active
VEA Align; spineEOS	K240582	FDA 510(k)	Class II	Active
spineEOS	K232086	FDA 510(k)	Class II	Active
sterEOS	sterEOS	EUDAMEDFDA UDI	Class IIa	Active
Radioluscent chair	9000113040	EUDAMEDFDA UDI	Class I	Active
EOSedge Chair	9000116089	EUDAMEDFDA UDI	Class I	Active
AutoDensity	AutoDensity	EUDAMED	Class IIa	Active
VEA Align	VEA Align	EUDAMEDFDA UDI	Class IIa	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 17, 2015	Z-1460-2015	—	terminated	When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.
Jun 19, 2012	Z-2072-2012	—	terminated	It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.

Establishments registered with the FDA under this company group, matched by name.