510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801168Substantially Equivalent

Collimax X-Ray Collimator # R-182

Ito X-Ray Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801168 is the FDA 510(k) clearance record for COLLIMAX X-RAY COLLIMATOR # R-182, a class II device, cleared for Ito X-Ray Corp. on under FDA product code IZX (Collimator, Manual, Radiographic). FDA records list one 510(k) clearance for Ito X-Ray Corp. As of , FDA records show no recalls naming K801168.

Clearance record

Decision date
Received
(54 days to decision)
Product code
IZX Collimator, Manual, Radiographic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
Ito X-Ray Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IZX

Trailing 12 months

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

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