Clearance Summary
TrackX received FDA 510(k) clearance under submission number K200360, sponsored by Track X Technology, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-03-05.
- Submission: K200360
- Applicant / Sponsor: Track X Technology, LLC
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2020-03-05
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.