免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

RadUnity (版本 1.0.0)

K号: K242810 · 2024-11-26

决定日期2024-11-26
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

RadUnity (Version 1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Radunity Corp.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K242810. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RadUnity (Version 1.0.0)?

RadUnity (Version 1.0.0) is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Radunity Corp.. The 510(k) number is K242810.

When did RadUnity (Version 1.0.0) receive FDA 510(k) clearance?

RadUnity (Version 1.0.0) received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242810.

Who is the listed applicant for RadUnity (Version 1.0.0)?

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

What is the FDA product code for RadUnity (Version 1.0.0)?

The FDA product code for RadUnity (Version 1.0.0) is LLZ.

相关临床试验

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。

相关器械(代码:LLZ)

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。

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。

↑