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510(k) K063846

EIGEN DSA 2000 by Eigen — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2007
Date Received
December 27, 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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