Cleared Traditional

K141837 - DRX-EVOLUTION

K141837 is the FDA 510(k) clearance for DRX-EVOLUTION by Carestream Health, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K141837 · Carestream Health, Inc. · Radiology device
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Mar 2015
Decision
247d
Days
Class 2
Risk

K141837 is an FDA 510(k) clearance for the DRX-EVOLUTION. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on March 11, 2015 after a review of 247 days - an extended review cycle.

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 Carestream Health, Inc. devices

Submission Details

510(k) Number K141837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date March 11, 2015
Days to Decision 247 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
140d slower than avg
Panel avg: 107d · This submission: 247d
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 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K141837.
GUA60A, GU60A-65
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XGEO GF50
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