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510(k) K852346

XISCAN MODEL 1000 by Xi Tech — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1986
Date Received
May 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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