510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941626Substantially Equivalent

Gridgil

Gilardoni S.p.A., Mandello Lario, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941626 is the FDA 510(k) clearance record for GRIDGIL, a class I device, cleared for Gilardoni S.P.A. on under FDA product code IXJ (Grid, Radiographic). FDA records list one 510(k) clearance for Gilardoni S.P.A. As of , FDA records show no recalls naming K941626.

Clearance record

Decision date
Received
(39 days to decision)
Product code
IXJ Grid, Radiographic
Regulation
21 CFR 892.1910
Device class
Class I
Review panel
Radiology
Applicant
Gilardoni S.P.A. 2, Via Fermi, Mandello Lario, IT
510(k) summary
Summary
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