510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062788Substantially Equivalent

Collimator, Model M-38

Umi International, Norwood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K062788 is the FDA 510(k) clearance record for COLLIMATOR, MODEL M-38, a class II device, cleared for Umi International on under FDA product code KPW (Device, Beam Limiting, X-Ray, Diagnostic). FDA records list one 510(k) clearance for Umi International. As of , FDA records show no recalls naming K062788.

Clearance record

Decision date
Received
(101 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
Umi International 129 Kensington Ave., Norwood NJ
510(k) summary
Statement
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