Aura 10 PET/CT— 510(k) K231420
Substantially EquivalentXeos Medical
FDA 510(k) clearance K231420 for Aura 10 PET/CT, Substantially Equivalent on 2023-08-10. Applicant: Xeos Medical. Device class: 2.
Clearance details
- Applicant
- Xeos Medical
- Product code
- Code QXL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gent, BE
Data sourced from openFDA. This site is unofficial and independent of the FDA.