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510(k) K901012

RADIOGRAPHIC GRID by Infab Corp. — Product Code IXJ

K901012 is an FDA 510(k) premarket notification submitted by Infab Corp. for the device "RADIOGRAPHIC GRID". The FDA issued a decision of Substantially Equivalent on March 28, 1990. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. Infab Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1990
Date Received
March 5, 1990
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 Infab Corp.

  • K900972 — RADIATION PROTECTION GLOVES (May 1, 1990)
  • K900970 — RADIATION PROTECTION GLASSES (May 1, 1990)
  • K901014 — RADIOGRAPHIC INTENSIFYING SCREEN (April 2, 1990)
  • K901013 — RADIOGRAPHIC FILM CASSETTE (March 28, 1990)
  • K896289 — RADIATION PROTECTION APRON (December 14, 1989)

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)
  • K926445 — SOYEE ALUMINUM INTERSPACED X-RAY GRID (April 7, 1993)
  • K926261 — JPI ALUMINUM INTERSPACED X-RAY GRID (March 18, 1993)

FDA data resources