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510(k) K941023

RAREX GREEN FAST by Mci Optonix, Inc. — Product Code EAM

K941023 is an FDA 510(k) premarket notification submitted by Mci Optonix, Inc. for the device "RAREX GREEN FAST". The FDA issued a decision of Substantially Equivalent on March 30, 1994. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Mci Optonix, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1994
Date Received
March 3, 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 Mci Optonix, Inc.

  • K953444 — MCI OPTONIX ECONOMY CASSETTE (August 2, 1995)
  • K945039 — MCI OPTONIX CASSETTE OKAMOTO CASSETE (November 22, 1994)
  • K902039 — RAREX & OPTEX X-RAY SCREENS (July 27, 1990)

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)
  • K942805 — KYOKKO BLUE SERIES INTENSIFYING SCREENS (July 29, 1994)
  • K942909 — KODAK INSIGHT TWIN-LOAD INSERT (July 29, 1994)

FDA data resources