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510(k) K171487

Sirius MRI Marker NS by C4 Imaging, LLC — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2017
Date Received
May 22, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

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