FDA 510(k)

TumorSight Risk

K号: K260023 · 2026-09-25

决定日期2026-09-25

产品代码SHW

咨询委员会PA

决定Substantially Equivalent

器械摘要

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.

常见问题

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.

列明SimBioSys, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251766TumorSight Viz K243189TumorSight Viz K231130TumorSight Viz

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。