K242948

Adora DRFi (04550010)

510(k) number
K242948
Device name
Adora DRFi (04550010)
Applicant
Nrt X-Ray A/S DK
Product code
JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Decision date
2024-12-23
Date received
2024-09-25
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
510(k) Summary (official FDA PDF): K242948.pdf
Official FDA record: K242948
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.