TumorSight Risk— 510(k) K260023
Substantially EquivalentSimBioSys, Inc.
FDA 510(k) clearance K260023 for TumorSight Risk, Substantially Equivalent on 2026-09-25. Applicant: SimBioSys, Inc.. Device class: 2.
Summary
TumorSight Risk is filed under SHW: pathology software that analyzes digital images for breast cancer prognosis. The record doesn't describe the inputs or the risk output beyond what that code name says.
Class II, 21 CFR 864.3755. The Pathology panel reviewed it as a Traditional 510(k).
SimBioSys, Inc. filed from Chicago, Illinois. Review took 263 days (January 5 to September 25, 2026).
Clearance details
- Applicant
- SimBioSys, Inc.
- Product code
- Product code SHW
- Device class
- Class 2
- Regulation
- 21 CFR 864.3755
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code SHW
view allMore clearances from SimBioSys, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.