510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103093Substantially Equivalent

Leksell Gammaplan

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

K103093 is the FDA 510(k) clearance record for LEKSELL GAMMAPLAN, a class II device, cleared for Elekta Instrument AB on under FDA product code MUJ (System, Planning, Radiation Therapy Treatment). FDA records list 35 510(k) clearances for Elekta Instrument AB, from to . As of , FDA records show one recall naming K103093.

Clearance record

Decision date
Received
(63 days to decision)
Product code
MUJ System, Planning, Radiation Therapy Treatment
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Elekta Instrument AB Kungstensgatan 18, Stockholm, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUJ

Trailing 12 months
12 clearances under product code MUJ in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MUJ, trailing twelve months
MonthClearances
November 20251
December 20253
January 20260
February 20262
March 20261
April 20260
May 20263
June 20261
July 20261
August 20260
September 20260
October 20260