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510(k) K151403

Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System by Neusoft Medical Systems Co., Ltd. — Product Code KPS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 2, 2015
Date Received: May 26, 2015
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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