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510(k) K945697

SK S-RAY GRIDS by Seibu Techno Coproration — Product Code IXJ

K945697 is an FDA 510(k) premarket notification submitted by Seibu Techno Coproration for the device "SK S-RAY GRIDS". The FDA issued a decision of Substantially Equivalent on January 31, 1995. 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
January 31, 1995
Date Received
November 17, 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)
  • 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