K260303
- 510(k) number
- K260303
- Device name
- See-Mode Augmented Reporting Tool, Breast (SMART-B)
- Applicant
- See-Mode Technologies Pty, Ltd. AU
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-07-28
- Date received
- 2026-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260303.pdf
Official FDA record: K260303
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.