FDA 510(k)

Saige-Dx (3.1.0)

K号: K243688 · 2024-12-19

决定日期2024-12-19

产品代码QDQ

咨询委员会RA

决定实质等同

器械摘要

Saige-Dx (3.1.0) is the device name listed in this FDA 510(k) record. The listed applicant is DeepHealth, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K243688. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Saige-Dx (3.1.0)?

Saige-Dx (3.1.0) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is DeepHealth, Inc.. The 510(k) number is K243688.

When did Saige-Dx (3.1.0) receive FDA 510(k) clearance?

Saige-Dx (3.1.0) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243688.

Who is the listed applicant for Saige-Dx (3.1.0)?

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

What is the FDA product code for Saige-Dx (3.1.0)?

The FDA product code for Saige-Dx (3.1.0) is QDQ.

列明DeepHealth, 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。

K253825Saige-Dx K254131BAC K251873Saige-Dx K243703TechLive K243705Saige-Density (2.5.0)K241747Saige-Dx

查看所有 10 个设备 →

官方来源

在 FDA 数据库中查看 →

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。