510(k) K231420
- Device
- Aura 10 PET/CT
- Applicant
- Xeos Medical
- 510(k) number
- K231420
- Product code
- QXL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-10
- Date received
- 2023-05-16
- Regulation
- 892.1200
- Classification name
- Cabinet, Emission Computed Tomography System
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Bjorn Delbeecke
- Address
- Ottergemsesteenweg-Zuid 808 Bus 358 Gent BE 9000 9000
FDA Registration Numbers
- 3027847687