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510(k) K951373

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ by Fujifilm Medical System U.S.A., Inc. — Product Code IXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1995
Date Received
March 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

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Other clearances for product code IXW

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  • K022154 — LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (September 30, 2002)
  • K002640 — FREEDOM AUTOMATIC FILM PROCESSOR (November 8, 2000)
  • K002404 — MICRO-MAX, MODEL 319 (August 30, 2000)