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510(k) K931002

FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS by Fujifilm Medical System U.S.A., Inc. — Product Code IXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1993
Date Received
February 26, 1993
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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  • K934949 — DIGORA (February 10, 1994)
  • K924459 — DIGISCAN 2 (December 17, 1992)
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