510(k) K231420

Aura 10 PET/CT by Xeos Medical — Product Code QXL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 10, 2023
Date Received: May 16, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

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

Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised during surgical procedures