510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853861Substantially Equivalent

Canon X-Ray i.i. Rapid Sequence Camera Crs-105

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

K853861 is the FDA 510(k) clearance record for CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105, a class I device, cleared for Canon USA, Inc. on under FDA product code IJZ (Oil, Clearing). 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 K853861.

Clearance record

Decision date
Received
(37 days to decision)
Product code
IJZ Oil, Clearing
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Canon USA, Inc. One Jericho Plz., Jericho NY
Third party review
No

Clearances, product code IJZ

Trailing 12 months

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

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