Cleared Traditional

Synergy Platform, Synergy, Infinity, VersaHD

K192242 · Elekta Limited · Radiology
Nov 2019
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K192242 is an FDA 510(k) clearance for the Synergy Platform, Synergy, Infinity, VersaHD, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Elekta Limited (Crawley, GB). The FDA issued a Cleared decision on November 22, 2019, 95 days after receiving the submission on August 19, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K192242 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2019
Decision Date November 22, 2019
Days to Decision 95 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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