510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904587Substantially Equivalent

Densicomp 250

L. Keroack Co., Canada H3x 3p3, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904587 is the FDA 510(k) clearance record for DENSICOMP 250, a class II device, cleared for L. Keroack Co. on under FDA product code KPW (Device, Beam Limiting, X-Ray, Diagnostic). FDA records list one 510(k) clearance for L. Keroack Co. As of , FDA records show no recalls naming K904587.

Clearance record

Decision date
Received
(107 days to decision)
Product code
KPW Device, Beam Limiting, X-Ray, Diagnostic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
L. Keroack Co. 4841 Wilson St., Canada H3x 3p3, CA
Third party review
No

Clearances, product code KPW

Trailing 12 months

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

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