Clearance Summary
BioTraceIO Precision (2.0) received FDA 510(k) clearance under submission number K243084, sponsored by Techsomed Medical Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-12-27.
- Submission: K243084
- Applicant / Sponsor: Techsomed Medical Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2052
- Decision date: 2024-12-27
Classification & Regulation
This clearance is catalogued under FDA product code QZL and 21 CFR 892.2052, within the Radiology review panel as a Class II device.