K251766
- 510(k) number
- K251766
- Device name
- TumorSight Viz
- Applicant
- SimBioSys, Inc. IL · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-07-08
- Date received
- 2025-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251766.pdf
Official FDA record: K251766
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.