Cleared Traditional

VARIAN MULTILEAF COLLIMATOR

K893464 · Varian Assoc., Inc. · Radiology
Aug 1989
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K893464 is an FDA 510(k) clearance for the VARIAN MULTILEAF COLLIMATOR, a Block, Beam-shaping, Radiation Therapy (Class II — Special Controls, product code IXI), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 10, 1989, 99 days after receiving the submission on May 3, 1989. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.

Submission Details

510(k) Number K893464 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1989
Decision Date August 10, 1989
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IXI — Block, Beam-shaping, Radiation Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5710