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510(k) K963913

MD100 & MM150 by Konica Medical Corp. — Product Code EAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1997
Date Received
September 30, 1996
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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  • K931316 — KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR (December 14, 1993)
  • K931315 — KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR (December 14, 1993)
  • K931317 — KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR (December 14, 1993)
  • K933830 — KONICA LD-4500 LASER DIGITIZER (December 14, 1993)
  • K931314 — KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR (September 7, 1993)
  • K931313 — KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR (September 7, 1993)
  • K931312 — KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR (September 7, 1993)

Other clearances for product code EAM

  • K974423 — ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (December 22, 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)
  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
  • K943425 — FUJI HG-M INTENSIFYING SCREEN (August 17, 1994)
  • K942235 — KYOKKO GREEN SERIES INTENSIFYING SCREENS (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)