Cleared Traditional

K920349 - PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR (FDA 510(k) Clearance)

Class I Radiology device.

K920349 · Control-X, Inc. · Radiology device
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Feb 1993
Decision
385d
Days
Class 1
Risk

K920349 is an FDA 510(k) clearance for the PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Control-X, Inc. (Columbus, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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. Elevated predicate reliance profile. 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 Control-X, Inc. devices

Submission Details

510(k) Number K920349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1992
Decision Date February 12, 1993
Days to Decision 385 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
278d slower than avg
Panel avg: 107d · This submission: 385d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.