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510(k) K110511

E4D COMPASS by D4D Technologies — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2011
Date Received
February 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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