Cleared Traditional

PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF (K032628) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 95
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K032628.
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