Eos Imaging
Medical device manufacturer in Paris, FR.
17510(k) clearances
0PMA approvals
8recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251078 | AutoDensityQIH · Traditional | 11/14/2025SE |
| K251747 | VEA Align; spineEOSQIH · Traditional | 08/15/2025SE |
| K233920 | EOSedgeKPR · Traditional | 08/06/2024SE |
| K240582 | VEA Align; spineEOSQIH · Traditional | 06/25/2024SE |
| K231917 | VEA AlignQIH · Traditional | 01/05/2024SE |
| K232086 | spineEOSLLZ · Traditional | 10/24/2023SE |
| K202394 | EOSedgeKPR · Special | 09/16/2020SE |
| K192079 | EOSedgeKPR · Traditional | 11/27/2019SE |
| K172346 | sterEOS WorkstationLLZ · Traditional | 06/19/2018SE |
| K160914 | sterEOS WorkstationLLZ · Special | 04/22/2016SE |
| K152788 | EOS SystemKPR · Special | 10/21/2015SE |
| K142773 | EOS SystemKPR · Traditional | 01/22/2015SE |
| K141137 | Stereos WorkstationLLZ · Traditional | 09/15/2014SE |
| K130395 | Stereos WorkstationLLZ · Special | 03/11/2013SE |
| K123740 | EosMQB · Special | 02/22/2013SE |
| K113344 | Stereos WorkstationLLZ · Traditional | 11/16/2012SE |
| K120721 | EosMQB · Special | 04/06/2012SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1415-2021 Class II | The EOSedge system may acquire two simultaneous orthogonal planar images for a standing…Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed… | 12/22/2020Terminated |
| Z-3188-2018 Class II | sterEOS workstation3D projections may be incorrect when the pair of images used is a secondary capture generated from a series… | 08/01/2018Terminated |
| Z-2626-2017 Class II | ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH…ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow… | 05/30/2017Terminated |
| Z-1460-2015 Class II | 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… | 02/17/2015Terminated |
| Z-0580-2014 Class II | steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D…Error copying information to the clinical file and to the report when two 3D models are opened… | 11/29/2013Terminated |
| Z-0529-2014 Class II | EOS System X- ray beam Digital radiography system used in general radiographic…EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the… | 11/07/2013Terminated |
| Z-2072-2012 Class II | EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in…It was discovered of several generator failures of the EOS System due to failure of its anode controller… | 06/19/2012Terminated |
| 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…Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in… | 04/13/2011Terminated |