Cleared Traditional

iViewDose R1.0

K153011 · Elekta Limited · Radiology
Dec 2015
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K153011 is an FDA 510(k) clearance for the iViewDose R1.0, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Elekta Limited (Crawley, GB). The FDA issued a Cleared decision on December 11, 2015, 58 days after receiving the submission on October 14, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K153011 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2015
Decision Date December 11, 2015
Days to Decision 58 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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