Clearance Summary
Intelli-C received FDA 510(k) clearance under submission number K173631, 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 2018-07-11.
- Submission: K173631
- 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: 2018-07-11
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.