Cleared Traditional

K032628 - PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF

K032628 is an FDA 510(k) clearance for PORTABLE X-RAY UNIT, manufactured by United Radiology Systems, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K032628 · United Radiology Systems, Inc. · Radiology device
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Feb 2004
Decision
160d
Days
Class 2
Risk

K032628 is an FDA 510(k) clearance for the PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by United Radiology Systems, Inc. (Deerfield, US). The FDA issued a Cleared decision on February 2, 2004 after a review of 160 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all United Radiology Systems, Inc. devices

FDA 510(k) Submission Details - K032628

510(k) Number K032628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2003
Decision Date February 02, 2004
Days to Decision 160 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 107d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 161
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K032628.
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