Cleared Traditional

VARIAN MULTILEAF COLLIMATOR

K943224 · Varian Assoc., Inc. · Radiology
Feb 1996
Decision
577d
Days
Class 2
Risk

About This 510(k) Submission

K943224 is an FDA 510(k) clearance for the VARIAN MULTILEAF COLLIMATOR, 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 February 2, 1996, 577 days after receiving the submission on July 5, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K943224 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1994
Decision Date February 02, 1996
Days to Decision 577 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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