510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210500Substantially Equivalent

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

Elekta Limited, Crawley, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210500 is the FDA 510(k) clearance record for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD, a class II device, cleared for Elekta Limited on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 58 510(k) clearances for Elekta Limited, from to . As of , FDA records show 10 recalls naming K210500.

Clearance record

Decision date
Received
(109 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Elekta Limited Linac House, Crawley, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYE

Trailing 12 months
16 clearances under product code IYE in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code IYE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20260
March 20261
April 20262
May 20261
June 20262
July 20260
August 20263
September 20261
October 20260