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510(k) K943821

KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC by Fujifilm Medical System U.S.A., Inc. — Product Code EAM

K943821 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC". The FDA issued a decision of Substantially Equivalent on August 22, 1994. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Fujifilm Medical System U.S.A., Inc.

  • K163675 — Processor VP-7000, Light Source BL-7000 (April 25, 2017)
  • K153206 — Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (March 3, 2016)
  • K151474 — Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (February 18, 2016)
  • K152138 — FDR D-EVO GL Flat Panel Detector System (November 5, 2015)
  • K150221 — EPX-4440HD and EPX-4400HD with FICE (October 1, 2015)
  • K142629 — EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (May 14, 2015)
  • K142003 — FDR D-EVO II FLAT PANEL DETECTOR SYSTEM (October 21, 2014)
  • K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR (September 9, 2014)
  • K132188 — MAMMOGRAPHY VIEWER SMV658 (October 25, 2013)
  • K130542 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (June 14, 2013)

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)
  • K943425 — FUJI HG-M INTENSIFYING SCREEN (August 17, 1994)
  • K942235 — KYOKKO GREEN SERIES INTENSIFYING SCREENS (August 17, 1994)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)
  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)
  • K942399 — KYOKKO UM SERIES INTENSIFYING SCREEN (June 10, 1994)

FDA data resources