Cleared Traditional

XVI R5.0

K131965 · Elekta Limited · Radiology
Sep 2013
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K131965 is an FDA 510(k) clearance for the XVI R5.0, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Elekta Limited (West Sussex, GB). The FDA issued a Cleared decision on September 25, 2013, 90 days after receiving the submission on June 27, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K131965 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2013
Decision Date September 25, 2013
Days to Decision 90 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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