Cleared Traditional

VARIAN ELECTRONIC PORTAL IMAGING SYSTEM

K901932 · Varian Assoc., Inc. · Radiology
May 1991
Decision
368d
Days
Class 2
Risk

About This 510(k) Submission

K901932 is an FDA 510(k) clearance for the VARIAN ELECTRONIC PORTAL IMAGING SYSTEM, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 3, 1991, 368 days after receiving the submission on April 30, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K901932 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 1990
Decision Date May 03, 1991
Days to Decision 368 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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