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510(k) K140269

HERMES MEDICAL IMAGING SUITE V5.4 by Hermes Medical Solutions AB — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2014
Date Received
February 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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