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510(k) K942561

FUJI FCR IMAGE PROCESSING UNIT IP-U515 by Fujifilm Medical System U.S.A., Inc. — Product Code IXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1994
Date Received
May 31, 1994
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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  • K923990 — FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (December 17, 1992)