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510(k) K862414

FUJI CR IMAGING PLATE by Parexel Intl. Corp. — Product Code EAM

K862414 is an FDA 510(k) premarket notification submitted by Parexel Intl. Corp. for the device "FUJI CR IMAGING PLATE". The FDA issued a decision of Substantially Equivalent on February 26, 1987. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Parexel Intl. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1987
Date Received
June 25, 1986
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 Parexel Intl. Corp.

  • K900385 — ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE (July 9, 1991)
  • K904902 — SMA 26 TRANSDUCER (March 26, 1991)
  • K904901 — L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC (March 26, 1991)
  • K884800 — ACTA GENOS ELECTROCARDIOGRAPH (June 22, 1989)
  • K864519 — PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) (February 13, 1987)
  • K862416 — FTI 100 MEDICAL THERMAL IMAGER (July 1, 1986)
  • K862415 — TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (July 1, 1986)
  • K853295 — EMODREN EXCHANGEABLE PLASTIC BELLOWS (August 20, 1985)
  • K853296 — EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (August 15, 1985)
  • K851322 — PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH (May 16, 1985)

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)
  • 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)

FDA data resources