Cleared Traditional

VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY

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

About This 510(k) Submission

K904169 is an FDA 510(k) clearance for the VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY, a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO), submitted by Varian Canada, Inc. (Canada L7g 2j4, CA). The FDA issued a Cleared decision on February 19, 1991, 161 days after receiving the submission on September 11, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K904169 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1990
Decision Date February 19, 1991
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IZO — Generator, High-voltage, X-ray, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1700

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