Cleared Traditional

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (K210500) - FDA 510(k) Clearance

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

K210500 · Elekta Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
109d
Days
Class 2
Risk

K210500 is an FDA 510(k) clearance for the Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD. 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 June 11, 2021 after a review of 109 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 K210500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 107d · This submission: 109d
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 Consultant

Elekta, Inc.
Lorenzo Muratori

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K210500.
Ethos Treatment Management, Ethos Treatment Planning
K212294 · Varian Medical Systems, Inc. · Aug 2021
Zap-X Radiosurgical System
K211663 · Zap Surgical Systems, Inc. · Jul 2021
ExacTrac Dynamic
K211939 · Brainlab AG · Jul 2021
Fiducial Marker
K211590 · Carbon Medical Technologies, Inc. · Jun 2021
C-Qual M™ Breastboard
K211001 · Medtec, Inc. Dba Civco Medical Solutions and Civco · May 2021
Klarity Bolus
K202747 · Klarity Medical & Equipment (GZ) Co., Ltd. · May 2021