Cleared Traditional

K921875 - X-RAY CONTROL AND HI-VOLTAGE GENERATOR (FDA 510(k) Clearance)

Class I Radiology device.

K921875 · Continental X-Ray Corp. · Radiology device
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Oct 1992
Decision
178d
Days
Class 1
Risk

K921875 is an FDA 510(k) clearance for the X-RAY CONTROL AND HI-VOLTAGE GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on October 15, 1992 after a review of 178 days - an extended review cycle.

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. 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 Continental X-Ray Corp. devices

Submission Details

510(k) Number K921875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1992
Decision Date October 15, 1992
Days to Decision 178 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
71d slower than avg
Panel avg: 107d · This submission: 178d
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.