510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K883527Substantially Equivalent

Grid/radiographic

Umi, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883527 is the FDA 510(k) clearance record for GRID/RADIOGRAPHIC, a class I device, cleared for Umi, Inc. on under FDA product code IXJ (Grid, Radiographic). FDA records list one 510(k) clearance for Umi, Inc. As of , FDA records show no recalls naming K883527.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IXJ Grid, Radiographic
Regulation
21 CFR 892.1910
Device class
Class I
Review panel
Radiology
Applicant
Umi, Inc. 2190 S. Mason Rd.,, St. Louis MO
Third party review
No

Clearances, product code IXJ

Trailing 12 months

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

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