Cleared Traditional

Elekta Unity

K192482 · Elekta Limited · Radiology
Dec 2019
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K192482 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 5, 2019, 86 days after receiving the submission on September 10, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K192482 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2019
Decision Date December 05, 2019
Days to Decision 86 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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