Clearance Summary
TCL3 Motion Tracking System received FDA 510(k) clearance under submission number K221785, sponsored by Tracinnovations 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 2022-08-29.
- Submission: K221785
- Applicant / Sponsor: Tracinnovations A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2022-08-29
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.