510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963893Substantially Equivalent

Fibre Interspaced X-Ray Grid

Smit Rontgen, Md Eindhoven, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963893 is the FDA 510(k) clearance record for FIBRE INTERSPACED X-RAY GRID, a class I device, cleared for Smit Rontgen on under FDA product code IXJ (Grid, Radiographic). FDA records list one 510(k) clearance for Smit Rontgen. As of , FDA records show no recalls naming K963893.

Clearance record

Decision date
Received
(41 days to decision)
Product code
IXJ Grid, Radiographic
Regulation
21 CFR 892.1910
Device class
Class I
Review panel
Radiology
Applicant
Smit Rontgen Postbox 218, Md Eindhoven, NL
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