Cleared Special

K171353 - CMDR 2ST (Multiple Models)

K171353 is an FDA 510(k) clearance for CMDR 2ST (Multiple Models), manufactured by Minxray, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Special 510(k) pathway after a 29-day FDA review.

K171353 · Minxray, Inc. · Radiology device
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Jun 2017
Decision
29d
Days
Class 2
Risk

K171353 is an FDA 510(k) clearance for the CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Minxray, Inc. (Northbrook, US). The FDA issued a Cleared decision on June 7, 2017 after a review of 29 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

FDA 510(k) Submission Details - K171353

510(k) Number K171353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date June 07, 2017
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

IZL Device Classification - Class 2, Special Controls

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

All 133
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