510(k) K231420
K231420 is an FDA 510(k) premarket notification submitted by Xeos Medical for the device "Aura 10 PET/CT". The FDA issued a decision of Substantially Equivalent on August 10, 2023. The device falls under product code QXL (Cabinet, Emission Computed Tomography System), a Class II device regulated under 21 CFR 892.1200.
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