510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844053Substantially Equivalent

Canon 60 Degree Fundus Camera Cf-60S

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

K844053 is the FDA 510(k) clearance record for CANON 60 DEGREE FUNDUS CAMERA CF-60S, a class II device, cleared for Canon USA, Inc. on under FDA product code HFI (Coagulator, Culdoscopic (And Accessories)). 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 K844053.

Clearance record

Decision date
Received
(62 days to decision)
Product code
HFI Coagulator, Culdoscopic (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Canon USA, Inc. One Canon Plz., Lake Success NY
Third party review
No

Clearances, product code HFI

Trailing 12 months

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

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