K243189
- 510(k) number
- K243189
- Device name
- TumorSight Viz
- Applicant
- SimBioSys, Inc. IL · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-10-25
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K243189.pdf
Official FDA record: K243189
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.