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510(k) K963893

FIBRE INTERSPACED X-RAY GRID by Smit Rontgen — Product Code IXJ

K963893 is an FDA 510(k) premarket notification submitted by Smit Rontgen for the device "FIBRE INTERSPACED X-RAY GRID". The FDA issued a decision of Substantially Equivalent on November 7, 1996. 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
November 7, 1996
Date Received
September 27, 1996
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)
  • 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)
  • K941626 — GRIDGIL (May 13, 1994)
  • 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