EOS imaging
PARIS Paris, FR
EOS imaging appears in FDA device records in PARIS Paris, FR. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for EOS imaging between 2012 and 2025. The busiest year on record is 2024, with 3. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251078 | AutoDensity | QIH | Substantially Equivalent | |
| K251747 | VEA Align; spineEOS | QIH | Substantially Equivalent | |
| K233920 | EOSedge | KPR | Substantially Equivalent | |
| K240582 | VEA Align; spineEOS | QIH | Substantially Equivalent | |
| K231917 | VEA Align | QIH | Substantially Equivalent | |
| K232086 | spineEOS | LLZ | Substantially Equivalent | |
| K202394 | EOSedge | KPR | Substantially Equivalent | |
| K192079 | EOSedge | KPR | Substantially Equivalent | |
| K172346 | sterEOS Workstation | LLZ | Substantially Equivalent | |
| K160914 | sterEOS Workstation | LLZ | Substantially Equivalent | |
| K152788 | EOS System | KPR | Substantially Equivalent | |
| K142773 | EOS System | KPR | Substantially Equivalent | |
| K141137 | STEREOS WORKSTATION | LLZ | Substantially Equivalent | |
| K130395 | STEREOS WORKSTATION | LLZ | Substantially Equivalent | |
| K123740 | EOS | MQB | Substantially Equivalent | |
| K113344 | STEREOS WORKSTATION | LLZ | Substantially Equivalent | |
| K120721 | EOS | MQB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006165260 | 3006165260 | EOS imaging | 32 rue Blanche, PARIS 75009 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1415-2021 | 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 limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below. | Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior). | Class II | Terminated | |
| Z-3188-2018 | 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 parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions. | Class II | Terminated | |
| Z-2626-2017 | 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, EOS Imaging Catalogue Number 9000111774. | 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 the patients hand or arm in the EOS cabin. | Class II | Terminated | |
| Z-1460-2015 | EOS, Digital radiography system used in general radiographic examinations. | 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. | Class II | Terminated | |
| Z-0580-2014 | 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 3D x-ray images. | Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation | Class II | Terminated | |
| Z-0529-2014 | 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. | Class II | Terminated | |
| Z-2072-2012 | EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination. | 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. | Class II | Terminated | |
| Z-2692-2011 | 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, 1.3.3.3671, 1.3.4.3740, 1.3.5.3915, 1.3.6.4272,1.4.1.4813,1.4.2.4850. EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X-ray images. | 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 | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain