STEREOS WORKSTATION— 510(k) K130395

Name: FDA 510(k) clearance K130395
Creator: U.S. Food and Drug Administration
Published: 2013-03-11

Substantially Equivalent

Eos Imaging, Inc.

FDA 510(k) clearance K130395 for STEREOS WORKSTATION, Substantially Equivalent on 2013-03-11. Applicant: Eos Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Eos Imaging, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2013-02-15
Decision date: 2013-03-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K160914 — sterEOS Workstation2016-04-22

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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 K130395

K-number listed on FDA's recall record

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.Class II·Terminated·EOS Imaging·20131129

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130395.

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