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510(k) K162314

IMACTIS CT-Navigation system by Imactis, Sas — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2018
Date Received
August 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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