FDA.report

510(k) K242948

Device
Adora DRFi (04550010)
Applicant
Nrt X-Ray A/S
510(k) number
K242948
Product code
JAA
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-23
Date received
2024-09-25
Regulation
892.1650
Classification name
System, X-Ray, Fluoroscopic, Image-Intensified
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
Mogens Ravn
Address
Birkegaardsvej 16 Hasselager DK 8361 8361

FDA Registration Numbers

Source Documents

510(k) summary PDF

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