Cleared Traditional

Synergy Platform, Synergy, Infinity, VersaHD (K192242) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192242 · Elekta Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
95d
Days
Class 2
Risk

K192242 is an FDA 510(k) clearance for the Synergy Platform, Synergy, Infinity, VersaHD. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Elekta Limited (Crawley, GB). The FDA issued a Cleared decision on November 22, 2019 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Elekta Limited devices

Submission Details

510(k) Number K192242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 107d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 227
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K192242.
AlignRT Plus
K193431 · Vision Rt, Ltd. · Jan 2020
Medical Radiation Dosimetry System microSTARii
K192196 · Landauer · Dec 2019
Elekta Unity
K192482 · Elekta Limited · Dec 2019
IDENTIFY
K192968 · Varian Medical Systems, Inc. · Nov 2019
MU2net
K191944 · Dosisoft · Oct 2019
Mobius3D
K192424 · Varian Medical Systems, Inc. · Oct 2019