Home / 510(k) Clearances / K926445

510(k) K926445

SOYEE ALUMINUM INTERSPACED X-RAY GRID by X-Ray Accessories Mfg. Co. — Product Code IXJ

K926445 is an FDA 510(k) premarket notification submitted by X-Ray Accessories Mfg. Co. for the device "SOYEE ALUMINUM INTERSPACED X-RAY GRID". The FDA issued a decision of Substantially Equivalent on April 7, 1993. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. X-Ray Accessories Mfg. Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1993
Date Received
December 23, 1992
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 by X-Ray Accessories Mfg. Co.

  • K930220 — CASSETTE, RADIOGRAPHIC FILM (April 13, 1993)

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)
  • K941626 — GRIDGIL (May 13, 1994)
  • K940309 — X-RAY GRID (RADIOLOGICAL GRID) (April 22, 1994)
  • K926261 — JPI ALUMINUM INTERSPACED X-RAY GRID (March 18, 1993)
  • K925997 — KODAK EKTASCAN SP CASSETTE (December 17, 1992)

FDA data resources