510(k) clearance
TumorSight Risk
- 510(k) number
- K260023
- Applicant
- SimBioSys, Inc.
- Decision date
- Sep 25, 2026
- Date received
- Jan 5, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SHW
- Device type
- Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
- Device class
- Class II
- Regulation
- 21 CFR 864.3755
- Advisory committee
- Pathology
- Statement or summary
- Summary
- Third party
- N
- Location
- Chicago, IL, US