510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790168Substantially Equivalent

Collimator, Bilaterial

Cmsi, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790168 is the FDA 510(k) clearance record for COLLIMATOR, BILATERIAL, a class II device, cleared for Cmsi on under FDA product code KQA (Device, Beam Limiting, X-Ray, Therapeutic). FDA records list 2 510(k) clearances for Cmsi. As of , FDA records show no recalls naming K790168.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KQA Device, Beam Limiting, X-Ray, Therapeutic
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Cmsi 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KQA

Trailing 12 months

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

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