Clearance Summary
See-Mode Augmented Reporting Tool, Thyroid (SMART-T) received FDA 510(k) clearance under submission number K240697, sponsored by See-Mode Technologies Pte, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-09-09.
- Submission: K240697
- Applicant / Sponsor: See-Mode Technologies Pte, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2090
- Decision date: 2024-09-09
Classification & Regulation
This clearance is catalogued under FDA product code QDQ and 21 CFR 892.2090, within the Radiology review panel as a Class II device.