510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K962338Substantially Equivalent

Radiographic Grid

Unidex Group, Inc., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962338 is the FDA 510(k) clearance record for RADIOGRAPHIC GRID, a class I device, cleared for Unidex Group, Inc. on under FDA product code IXJ (Grid, Radiographic). FDA records list 2 510(k) clearances for Unidex Group, Inc. As of , FDA records show no recalls naming K962338.

Clearance record

Decision date
Received
(16 days to decision)
Product code
IXJ Grid, Radiographic
Regulation
21 CFR 892.1910
Device class
Class I
Review panel
Radiology
Applicant
Unidex Group, Inc. 2400 E. Devon Ave., Des Plaines IL
510(k) summary
Statement
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