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510(k) K180091

UNiD Spine Analyzer by Medicrea International — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2018
Date Received
January 12, 2018
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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