FDA 510(k)

TumorSight Viz

K-Number: K231130 · 2023-12-26

Decision Date2023-12-26

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TumorSight Viz is the device name listed in this FDA 510(k) record. The listed applicant is SimBioSys, Inc.. It received FDA 510(k) clearance on 2023-12-26 under 510(k) number K231130. 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 2023-12-26. The listed applicant is SimBioSys, Inc.. The 510(k) number is K231130.

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

TumorSight Viz received FDA 510(k) clearance on 2023-12-26, under 510(k) number K231130.

Who is the listed applicant for TumorSight Viz?

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 Viz?

The FDA product code for TumorSight Viz is QIH.

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

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Official Source

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