K240697
- 510(k) number
- K240697
- Device name
- See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
- Applicant
- See-Mode Technologies Pte, Ltd. SG
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2024-09-09
- Date received
- 2024-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K240697.pdf
Official FDA record: K240697
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.