510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212114Substantially Equivalent

Elekta Unity

Elekta Solutions AB, Stockholm, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212114 is the FDA 510(k) clearance record for Elekta Unity, a class II device, cleared for Elekta Solutions AB on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 15 510(k) clearances for Elekta Solutions AB, from to . As of , FDA records show one recall naming K212114.

Clearance record

Decision date
Received
(86 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Elekta Solutions AB Kungstensgatan 18 Box 7593, Stockholm, SE
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