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510(k) K924012

FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE by Fujifilm Medical System U.S.A., Inc. — Product Code IXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1992
Date Received
August 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, X-Ray, Electrostatic
Device Class
Class II
Regulation Number
892.1630
Review Panel
RA
Submission Type

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Other clearances for product code IXK

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  • K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (January 2, 2002)
  • K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (February 16, 2000)
  • K942561 — FUJI FCR IMAGE PROCESSING UNIT IP-U515 (December 23, 1994)
  • K934949 — DIGORA (February 10, 1994)
  • K931002 — FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (June 8, 1993)
  • K924459 — DIGISCAN 2 (December 17, 1992)