Clearance Summary
Adora DRFi (04550010) received FDA 510(k) clearance under submission number K242948, sponsored by Nrt X-Ray A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-12-23.
- Submission: K242948
- Applicant / Sponsor: Nrt X-Ray A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2024-12-23
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.