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510(k) K941626

GRIDGIL by Gilardoni S.P.A. — Product Code IXJ

K941626 is an FDA 510(k) premarket notification submitted by Gilardoni S.P.A. for the device "GRIDGIL". The FDA issued a decision of Substantially Equivalent on May 13, 1994. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1994
Date Received
April 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Radiographic
Device Class
Class I
Regulation Number
892.1910
Review Panel
RA
Submission Type

Other clearances for product code IXJ

  • K964025 — MITAYA ALUMINUM INTERSPACED X-RAY GRID (June 13, 1997)
  • K963893 — FIBRE INTERSPACED X-RAY GRID (November 7, 1996)
  • K962338 — RADIOGRAPHIC GRID (July 3, 1996)
  • K954294 — HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES (February 2, 1996)
  • K945697 — SK S-RAY GRIDS (January 31, 1995)
  • K945327 — JPI X-RAY GRID (January 20, 1995)
  • K940309 — X-RAY GRID (RADIOLOGICAL GRID) (April 22, 1994)
  • K926445 — SOYEE ALUMINUM INTERSPACED X-RAY GRID (April 7, 1993)
  • K926261 — JPI ALUMINUM INTERSPACED X-RAY GRID (March 18, 1993)
  • K925997 — KODAK EKTASCAN SP CASSETTE (December 17, 1992)

FDA data resources