Cleared Traditional

K142773 - EOS System

K142773 is an FDA 510(k) clearance for EOS System, manufactured by Eos Imaging. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K142773 · Eos Imaging · Radiology device
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Jan 2015
Decision
119d
Days
Class 2
Risk

K142773 is an FDA 510(k) clearance for the EOS System. 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 January 22, 2015 after a review of 119 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

FDA 510(k) Submission Details - K142773

510(k) Number K142773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date January 22, 2015
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

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 Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPR System, X-ray, Stationary

All 299
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K142773.
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