Cleared Traditional

K904169 - VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY (FDA 510(k) Clearance)

Class I Radiology device.

K904169 · Varian Canada, Inc. · Radiology device
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Feb 1991
Decision
161d
Days
Class 1
Risk

K904169 is an FDA 510(k) clearance for the VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Varian Canada, Inc. (Canada L7g 2j4, CA). The FDA issued a Cleared decision on February 19, 1991 after a review of 161 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 Varian Canada, Inc. devices

Submission Details

510(k) Number K904169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date February 19, 1991
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 107d · This submission: 161d
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.