Clearance Summary
See-Mode Augmented Reporting Tool, Breast (SMART-B) received FDA 510(k) clearance under submission number K260303, sponsored by See-Mode Technologies Pty, 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 2026-07-28.
- Submission: K260303
- Applicant / Sponsor: See-Mode Technologies Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2090
- Decision date: 2026-07-28
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.