510(k) K260023
- Device
- TumorSight Risk
- Applicant
- SimBioSys, Inc.
- 510(k) number
- K260023
- Product code
- SHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-25
- Date received
- 2026-01-05
- Regulation
- 864.3755
- Classification name
- Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Joseph Peterson
- Address
- 320 N Sangamon St., Suite 700 Chicago IL US 60607 60607
Source Documents#
Other 510(k) Records For Product Code SHW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254115 | ArteraAI Breast | Artera, Inc. | 2026-05-04 |