510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955484Substantially Equivalent

Xenon Option to Prism 3000

Philips North America LLC, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955484 is the FDA 510(k) clearance record for XENON OPTION TO PRISM 3000, a class II device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K955484.

Clearance record

Decision date
Received
(119 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems (Cleveland), Inc. 595 Miner Rd., Cleveland OH
510(k) summary
Summary
Third party review
No

Clearances, product code KPS

Trailing 12 months
8 clearances under product code KPS in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPS, trailing twelve months
MonthClearances
December 20252
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20261
October 20260
November 20260