510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K923851Substantially Equivalent

Acqsim Simulator/localizer

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

K923851 is the FDA 510(k) clearance record for ACQSIM SIMULATOR/LOCALIZER, a class II device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code KPQ (System, Simulation, Radiation Therapy). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K923851.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KPQ System, Simulation, Radiation Therapy
Regulation
21 CFR 892.5840
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems (Cleveland), Inc. 5500 Avion Park Dr., Highland Heights OH
510(k) summary
Summary
Third party review
No

Clearances, product code KPQ

Trailing 12 months

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

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