510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925302Substantially Equivalent

Philips Integris H/hm System

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

K925302 is the FDA 510(k) clearance record for PHILIPS INTEGRIS H/HM SYSTEM, a class II device, cleared for Philips Medical Systems, Inc. on under FDA product code IZF (System, X-Ray, Tomographic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 5 recalls naming K925302.

Clearance record

Decision date
Received
(57 days to decision)
Product code
IZF System, X-Ray, Tomographic
Regulation
21 CFR 892.1740
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems, Inc. Veenpluis 4-6, 5680 Da Best, NL
510(k) summary
Statement
Third party review
No

Clearances, product code IZF

Trailing 12 months
2 clearances under product code IZF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260