510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811967Substantially Equivalent

Cp-625 See-Thru Film Changer

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

K811967 is the FDA 510(k) clearance record for CP-625 SEE-THRU FILM CHANGER, a class II device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code KPX (Changer, Radiographic Film/Cassette). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K811967.

Clearance record

Decision date
Received
(34 days to decision)
Product code
KPX Changer, Radiographic Film/Cassette
Regulation
21 CFR 892.1860
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems (Cleveland), Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPX

Trailing 12 months

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

FDA records show no clearances under product code KPX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPX, 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