510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851067Substantially Equivalent

Canon X-Ray Film Changer Cfc-U1

Canon Medical Components U.S.A., Inc., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851067 is the FDA 510(k) clearance record for CANON X-RAY FILM CHANGER CFC-U1, a class II device, cleared for Canon USA, Inc. on under FDA product code KPX (Changer, Radiographic Film/Cassette). FDA records list 48 510(k) clearances for Canon Medical Components U.S.A., Inc., from to . As of , FDA records show no recalls naming K851067.

Clearance record

Decision date
Received
(64 days to decision)
Product code
KPX Changer, Radiographic Film/Cassette
Regulation
21 CFR 892.1860
Device class
Class II
Review panel
Radiology
Applicant
Canon USA, Inc. One Canon Plz., Lake Success NY
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