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FDA 510(k)

TumorSight Viz

K-Number: K251766 · 2025-07-08

ApplicantSimBioSys, Inc.
Decision Date2025-07-08
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TumorSight Viz is a medical device manufactured by SimBioSys, Inc.. It received FDA 510(k) clearance on 2025-07-08 under approval number K251766. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TumorSight Viz?

TumorSight Viz is a medical device that received FDA 510(k) clearance on 2025-07-08. It is manufactured by SimBioSys, Inc.. The 510(k) number is K251766.

When was TumorSight Viz approved by the FDA?

TumorSight Viz received FDA 510(k) clearance on 2025-07-08, under approval number K251766.

What company makes TumorSight Viz?

TumorSight Viz is manufactured by SimBioSys, Inc..

What is the FDA product code for TumorSight Viz?

The FDA product code for TumorSight Viz is QIH.

Other Devices by SimBioSys, Inc.

K231130TumorSight Viz K243189TumorSight Viz

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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.

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