Cleared Traditional

VPW 2877E6 X-RAY POWER SUPPLY

K910820 · Varian Canada, Inc. · Radiology
Mar 1991
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K910820 is an FDA 510(k) clearance for the VPW 2877E6 X-RAY POWER 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 March 7, 1991, 10 days after receiving the submission on February 25, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K910820 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1991
Decision Date March 07, 1991
Days to Decision 10 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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