Cleared Traditional

VARIAN CLINAC 600SR

K913174 · Varian Assoc., Inc. · Radiology
Nov 1991
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K913174 is an FDA 510(k) clearance for the VARIAN CLINAC 600SR, 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 November 5, 1991, 125 days after receiving the submission on July 3, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K913174 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1991
Decision Date November 05, 1991
Days to Decision 125 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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

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