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510(k) K081829

CAPIMAGE by Danish Diagnostic Development A/S — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2008
Date Received
June 27, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

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