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510(k) K901014

RADIOGRAPHIC INTENSIFYING SCREEN by Infab Corp. — Product Code EAM

K901014 is an FDA 510(k) premarket notification submitted by Infab Corp. for the device "RADIOGRAPHIC INTENSIFYING SCREEN". The FDA issued a decision of Substantially Equivalent on April 2, 1990. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Infab Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1990
Date Received
March 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Intensifying, Radiographic
Device Class
Class I
Regulation Number
892.1960
Review Panel
RA
Submission Type

Other clearances by Infab Corp.

  • K900972 — RADIATION PROTECTION GLOVES (May 1, 1990)
  • K900970 — RADIATION PROTECTION GLASSES (May 1, 1990)
  • K901012 — RADIOGRAPHIC GRID (March 28, 1990)
  • K901013 — RADIOGRAPHIC FILM CASSETTE (March 28, 1990)
  • K896289 — RADIATION PROTECTION APRON (December 14, 1989)

Other clearances for product code EAM

  • K974423 — ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (December 22, 1997)
  • K963913 — MD100 & MM150 (October 8, 1997)
  • K954161 — JPI INTENSIFYING SCREEN (February 2, 1996)
  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
  • K943823 — FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (August 22, 1994)
  • K943821 — KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (August 22, 1994)
  • K942235 — KYOKKO GREEN SERIES INTENSIFYING SCREENS (August 17, 1994)
  • K943425 — FUJI HG-M INTENSIFYING SCREEN (August 17, 1994)
  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)

FDA data resources