EOSedge— 510(k) K202394

Name: FDA 510(k) clearance K202394
Creator: U.S. Food and Drug Administration
Published: 2020-09-16

Substantially Equivalent

Eos Imaging

FDA 510(k) clearance K202394 for EOSedge, Substantially Equivalent on 2020-09-16. Applicant: Eos Imaging. Device class: 2.

Clearance details

Applicant: Eos Imaging
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-08-21
Decision date: 2020-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K202394

K-number listed on FDA's recall record

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.Class II·Terminated·EOS Imaging·20201222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202394.

Data sourced from openFDA. This site is unofficial and independent of the FDA.