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510(k) K140445

DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC by Imaging Sciences International, LLC — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2014
Date Received
February 21, 2014
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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