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FDA 510(k)

Imagine® Enterprise Suite

K号: K252634 · 2026-01-16

申请人Softlink International Private Limited
决定日期2026-01-16
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

Imagine® Enterprise Suite is the device name listed in this FDA 510(k) record. The listed applicant is Softlink International Private Limited. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K252634. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Imagine® Enterprise Suite?

Imagine® Enterprise Suite is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Softlink International Private Limited. The 510(k) number is K252634.

When did Imagine® Enterprise Suite receive FDA 510(k) clearance?

Imagine® Enterprise Suite received FDA 510(k) clearance on 2026-01-16, under 510(k) number K252634.

Who is the listed applicant for Imagine® Enterprise Suite?

The FDA 510(k) record lists Softlink International Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Imagine® Enterprise Suite?

The FDA product code for Imagine® Enterprise Suite is QIH.

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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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：QIH）

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。

K260055syngo.CT 脑部量化Siemens Medical Solutions USA, Inc.K262390骨专家VisianaK261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC软件仅用 / EchoPAC插件（v211）GE Medical Systems Ultrasound and Primary Care DiagnosticsK261677人工智能肾脏评估（AIRA）版本 1Aramis Global AI Consultancies, LLCK2608794DMINVIA, LLC

官方来源

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