K231130
- 510(k) number
- K231130
- Device name
- TumorSight Viz
- Applicant
- SimBioSys, Inc. IL · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2023-12-26
- Date received
- 2023-04-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231130.pdf
Official FDA record: K231130
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.