K250290
- 510(k) number
- K250290
- Device name
- SurgiTwin
- Applicant
- Twinsight FR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-08-29
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250290.pdf
Official FDA record: K250290
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.