FDA 510(k)

微创前列腺手术导航系统（型号：AmaKris SR1-A-2）

K号: K242314 · 2025-09-11

申请人Augment Intelligent Medical System (China) Co., Ltd.

决定日期2025-09-11

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) is the device name listed in this FDA 510(k) record. The listed applicant is Augment Intelligent Medical System (China) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K242314. 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 Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)?

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Augment Intelligent Medical System (China) Co., Ltd.. The 510(k) number is K242314.

When did Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) receive FDA 510(k) clearance?

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) received FDA 510(k) clearance on 2025-09-11, under 510(k) number K242314.

Who is the listed applicant for Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)?

The FDA 510(k) record lists Augment Intelligent Medical System (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)?

The FDA product code for Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) is LLZ.

列明Augment Intelligent Medical System (China) Co., Ltd.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。

K221499微创前列腺手术导航系统

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