EOS— 510(k) K123740

Substantially Equivalent

Eos Imaging

FDA 510(k) clearance K123740 for EOS, Substantially Equivalent on 2013-02-22. Applicant: Eos Imaging. Device class: 2.

Clearance details

Applicant: Eos Imaging
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2012-12-05
Decision date: 2013-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Eos Imaging

Recalls naming K123740

K-number listed on FDA's recall record

Z-1460-2015 — EOS, Digital radiography system used in general radiographic examinations.Class II·Terminated·Eos Imaging Inc·20150217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123740.

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