Cleared Special

K153059 - HF1202H PowerPlus Portable X-ray Equipment

K153059 is an FDA 510(k) clearance for HF1202H PowerPlus Portable X-ray Equipment, 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 104-day FDA review.

K153059 · Minxray, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
104d
Days
Class 2
Risk

K153059 is an FDA 510(k) clearance for the HF1202H PowerPlus Portable X-ray Equipment. 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 February 2, 2016 after a review of 104 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K153059

510(k) Number K153059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2015
Decision Date February 02, 2016
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
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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