Cleared Special

K040046 - MINXRAY

K040046 is an FDA 510(k) clearance for MINXRAY, 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 21-day FDA review.

K040046 · Minxray, Inc. · Radiology device
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Feb 2004
Decision
21d
Days
Class 2
Risk

K040046 is an FDA 510(k) clearance for the MINXRAY, MODEL HF120/60H POWERPLUS. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Minxray, Inc. (Deer Field, US). The FDA issued a Cleared decision on February 2, 2004 after a review of 21 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 - K040046

510(k) Number K040046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2004
Decision Date February 02, 2004
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K040046.
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