Cleared Special

K052721 - MINXRAY, MODEL HF100H+

K052721 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 28-day FDA review.

K052721 · Minxray, Inc. · Radiology device
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Oct 2005
Decision
28d
Days
Class 2
Risk

K052721 is an FDA 510(k) clearance for the MINXRAY, MODEL HF100H+. 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 October 27, 2005 after a review of 28 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 - K052721

510(k) Number K052721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date October 27, 2005
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 188
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K052721.
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