Aura 10 PET/CT— 510(k) K231420

Substantially Equivalent

Xeos Medical

FDA 510(k) clearance K231420 for Aura 10 PET/CT, Substantially Equivalent on 2023-08-10. Applicant: Xeos Medical.

Clearance details

Applicant: Xeos Medical
Product code: Code QXL
Advisory panel: Radiology
Date received: 2023-05-16
Decision date: 2023-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gent, BE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.