Data / Medical devices / France / EOS imaging

EOS imaging: FDA-registered device maker in Paris, France, 5 510(k) clearances

Name: EOS imaging FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

EOS imaging is registered with the FDA (registration 3006165260) in Paris, France. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 14, 2025. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006165260
Address: 32 rue Blanche, Paris, France, 75009
Owner or operator: EOS imaging (10022240)
Roles: Manufacturer
First device listed: July 13, 2016
Registered through: 2027
Brand names listed: AutoDensity, EOSedge, EOSedge chair, Radiolucent chair, VEA Align, spineEOS, sterEOS

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Chair, With Casters	INM	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 14, 2025	K251078	AutoDensity	QIH	Substantially Equivalent	Eos Imaging	accessdata.fda.gov
August 15, 2025	K251747	VEA Align; spineEOS	QIH	Substantially Equivalent	Eos Imaging	accessdata.fda.gov
August 6, 2024	K233920	EOSedge	KPR	Substantially Equivalent	Eos Imaging	accessdata.fda.gov
June 25, 2024	K240582	VEA Align; spineEOS	QIH	Substantially Equivalent	Eos Imaging	accessdata.fda.gov
June 19, 2018	K172346	sterEOS Workstation	LLZ	Substantially Equivalent	Eos Imaging	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 22, 2020	87505	Class II	Terminated	The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower	Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).	accessdata.fda.gov
August 1, 2018	80938	Class II	Terminated	sterEOS workstation	3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical par	accessdata.fda.gov
May 30, 2017	77424	Class II	Terminated	ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S	ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do not use grab handles to help patient up. The handles are only for stabilizing th	accessdata.fda.gov
November 29, 2013	66980	Class II	Terminated	steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance, transfer, display and digital processing of two	Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation	accessdata.fda.gov
November 7, 2013	66833	Class II	Terminated	EOS System X- ray beam Digital radiography system used in general radiographic examinations.	EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.	accessdata.fda.gov
April 13, 2011	58560	Not yet classified	Terminated	Software versions Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10,.2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2. sterEOS software versions: 1.2.3.3788, 1.2.4.4286, 1.3.2.3373, 1.3.3.3	Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing. T	accessdata.fda.gov

Compare with other makers

Updated November 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.