See-Mode Augmented Reporting Tool, Breast (SMART-B)— 510(k) K260303
Substantially EquivalentSee-Mode Technologies Pty, Ltd.
FDA 510(k) clearance K260303 for See-Mode Augmented Reporting Tool, Breast (SMART-B), Substantially Equivalent on 2026-07-28. Applicant: See-Mode Technologies Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- See-Mode Technologies Pty, Ltd.
- Product code
- Code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melbourne, AU
Recent devices under product code QDQ
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