Cleared Traditional

EOSedge (K192079) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192079 · Eos Imaging · Radiology device
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Nov 2019
Decision
117d
Days
Class 2
Risk

K192079 is an FDA 510(k) clearance for the EOSedge. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Eos Imaging (Paris, FR). The FDA issued a Cleared decision on November 27, 2019 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eos Imaging devices

Submission Details

510(k) Number K192079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2019
Decision Date November 27, 2019
Days to Decision 117 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 107d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPR System, X-ray, Stationary

All 117
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K192079.
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DIAMOND-5A/6A/8A
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