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510(k) K063344

CAAS QCA 3D by Pie Medical Imaging BV — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2006
Date Received
November 6, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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