Eos Imaging
Eos Imaging holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2025, with 5 FDA device recalls on record.
Top product codes for Eos Imaging
FDA recalls by Eos Imaging
- 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.
- Z-3188-2018 — sterEOS workstation
- 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.
- 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.
- Z-0529-2014 — EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Eos Imaging
- K251078 — AutoDensity
- K251747 — VEA Align; spineEOS
- K233920 — EOSedge
- K240582 — VEA Align; spineEOS
- K231917 — VEA Align
- K232086 — spineEOS
- K202394 — EOSedge
- K192079 — EOSedge
- K172346 — sterEOS Workstation
- K152788 — EOS System
- K142773 — EOS System
- K141137 — STEREOS WORKSTATION
- K123740 — EOS
- K113344 — STEREOS WORKSTATION
- K120721 — EOS
Data sourced from openFDA. This site is unofficial and independent of the FDA.