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510(k) K963913

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

K963913 is an FDA 510(k) premarket notification submitted by Konica Medical Corp. for the device "MD100 & MM150". The FDA issued a decision of Substantially Equivalent on October 8, 1997. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Konica Medical Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Konica Medical Corp.

  • K990969 — KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR (June 18, 1999)
  • K963914 — CM & CM DS-7 (October 8, 1997)
  • K955583 — VIFS (May 14, 1996)
  • K931317 — KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR (December 14, 1993)
  • K933830 — KONICA LD-4500 LASER DIGITIZER (December 14, 1993)
  • K931315 — KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR (December 14, 1993)
  • K931316 — KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR (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)
  • K943822 — FUJI UM MAMMO SERIES INTENSIFY SCREENS: (August 22, 1994)
  • K943821 — KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (August 22, 1994)
  • K943823 — FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (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)

FDA data resources