FDA 510(k)

TumorSight Risk

K-Number: K260023 · 2026-09-25

Decision Date2026-09-25

Product CodeSHW

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

TumorSight Risk is the device name listed in this FDA 510(k) record. The listed applicant is SimBioSys, Inc.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K260023. The device is classified under product code SHW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TumorSight Risk?

TumorSight Risk is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is SimBioSys, Inc.. The 510(k) number is K260023.

When did TumorSight Risk receive FDA 510(k) clearance?

TumorSight Risk received FDA 510(k) clearance on 2026-09-25, under 510(k) number K260023.

Who is the listed applicant for TumorSight Risk?

The FDA 510(k) record lists SimBioSys, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TumorSight Risk?

The FDA product code for TumorSight Risk is SHW.

Other records listing SimBioSys, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251766TumorSight Viz K243189TumorSight Viz K231130TumorSight Viz

Related Devices (Code: SHW)

K254115ArteraAI BreastArtera, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.