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510(k) K120367

3MENSIO WORKSTATION by Pie Medical Imaging BV — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2012
Date Received
February 6, 2012
Clearance Type
Traditional
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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