Cleared Special

CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY (K141885) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K141885 · Minxray, Inc. · Radiology device
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Sep 2014
Decision
69d
Days
Class 2
Risk

K141885 is an FDA 510(k) clearance for the CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Minxray, Inc. (Naples, US). The FDA issued a Cleared decision on September 18, 2014 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Minxray, Inc. devices

Submission Details

510(k) Number K141885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2014
Decision Date September 18, 2014
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

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