510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923141Substantially Equivalent

Philips Pre-Filter Option

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

K923141 is the FDA 510(k) clearance record for PHILIPS PRE-FILTER OPTION, a class I device, cleared for Philips Medical Systems, Inc. on under FDA product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K923141.

Clearance record

Decision date
Received
(206 days to decision)
Product code
ITY Assembly, Tube Housing, X-Ray, Diagnostic
Regulation
21 CFR 892.1760
Device class
Class I
Review panel
Radiology
Applicant
Philips Medical Systems, Inc. Veenpluis 4-6, 5680 Da Best, NL
510(k) summary
Summary
Third party review
No

Clearances, product code ITY

Trailing 12 months

FDA records hold no clearances under product code ITY in the trailing twelve months.

FDA records show no clearances under product code ITY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ITY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260