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510(k) K943822

FUJI UM MAMMO SERIES INTENSIFY SCREENS: by Fujifilm Medical System U.S.A., Inc. — Product Code EAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1994
Date Received
June 15, 1994
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

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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)
  • 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)
  • K942399 — KYOKKO UM SERIES INTENSIFYING SCREEN (June 10, 1994)