510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904124Substantially Equivalent

Philips Multileaf Collimator (Mlc)

Philips North America LLC, 5680 Da Best, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904124 is the FDA 510(k) clearance record for PHILIPS MULTILEAF COLLIMATOR (MLC), a class II device, cleared for Philips Medical Systems, Inc. on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K904124.

Clearance record

Decision date
Received
(146 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems, Inc. Veenpluis 4-6, 5680 Da Best, NL
Third party review
No

Clearances, product code IXI

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