Cleared Traditional

Elekta Unity

K182076 · Elekta Limited · Radiology
Dec 2018
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K182076 is an FDA 510(k) clearance for the Elekta Unity, 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 4, 2018, 125 days after receiving the submission on August 1, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K182076 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2018
Decision Date December 04, 2018
Days to Decision 125 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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