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510(k) K000976

DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) by Instrumentarium Imaging, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2000
Date Received
March 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

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