Cleared Special

K152788 - EOS System

K152788 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 Special 510(k) pathway after a 26-day FDA review.

K152788 · Eos Imaging · Radiology device
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Oct 2015
Decision
26d
Days
Class 2
Risk

K152788 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 October 21, 2015 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eos Imaging devices

FDA 510(k) Submission Details - K152788

510(k) Number K152788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2015
Decision Date October 21, 2015
Days to Decision 26 days
Submission Type Special
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
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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
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