Cleared Traditional

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

K210500 · Elekta Limited · Radiology
Jun 2021
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K210500 is an FDA 510(k) clearance for the Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Elekta Limited (Crawley, GB). The FDA issued a Cleared decision on June 11, 2021, 109 days after receiving the submission on February 22, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K210500 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2021
Decision Date June 11, 2021
Days to Decision 109 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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