510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011816Substantially Equivalent

Mini Multileaf Collimator, Model Kmi

Mrc Systems GmbH, Heidelberg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011816 is the FDA 510(k) clearance record for MINI MULTILEAF COLLIMATOR, MODEL KMI, a class II device, cleared for Mrc Systems GmbH on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 3 510(k) clearances for Mrc Systems GmbH, from to . As of , FDA records show no recalls naming K011816.

Clearance record

Decision date
Received
(88 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
Mrc Systems GmbH Hans-Bunte-Str. 10, Heidelberg, DE
510(k) summary
Summary
Third party review
No

Clearances, product code IXI

Trailing 12 months
1 clearance under product code IXI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260