Cleared Traditional

APEX

K111676 · Elekta Limited · Radiology
Sep 2011
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K111676 is an FDA 510(k) clearance for the APEX, a Block, Beam-shaping, Radiation Therapy (Class II — Special Controls, product code IXI), submitted by Elekta Limited (West Sussex, GB). The FDA issued a Cleared decision on September 30, 2011, 107 days after receiving the submission on June 15, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.

Submission Details

510(k) Number K111676 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2011
Decision Date September 30, 2011
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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