Cleared Traditional

HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR

K953582 · Varian Canada, Inc. · Radiology
Sep 1995
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K953582 is an FDA 510(k) clearance for the HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR, 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 September 26, 1995, 56 days after receiving the submission on August 1, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K953582 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1995
Decision Date September 26, 1995
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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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