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510(k) K122427

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE by Carestream Dental, LLC — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2012
Date Received
August 9, 2012
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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