Cleared Special

K162224 - ArtPix Mobile EZ2GO

K162224 is the FDA 510(k) clearance for ArtPix Mobile EZ2GO by Cmt Medical Technologies, Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Special 510(k) pathway after a 45-day FDA review.

K162224 · Cmt Medical Technologies, Ltd. · Radiology device
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Sep 2016
Decision
45d
Days
Class 2
Risk

K162224 is an FDA 510(k) clearance for the ArtPix Mobile EZ2GO. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Cmt Medical Technologies, Ltd. (Yoqneam Ilit, IL). The FDA issued a Cleared decision on September 22, 2016 after a review of 45 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 Cmt Medical Technologies, Ltd. devices

Submission Details

510(k) Number K162224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date September 22, 2016
Days to Decision 45 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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 165
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