FDA 510(k)

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

K-Number: K242314 · 2025-09-11

ApplicantAugment Intelligent Medical System (China) Co., Ltd.

Decision Date2025-09-11

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) is a medical device manufactured by Augment Intelligent Medical System (China) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-11 under approval number K242314. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Augment Intelligent Medical System (China) Co., Ltd.. The 510(k) number is K242314.

When was Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) approved by the FDA?

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

What company makes Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)?

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) is manufactured by Augment Intelligent Medical System (China) Co., Ltd..

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.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Augment Intelligent Medical System (China) Co., Ltd.

K221499Minimally Invasive Prostate Surgery Navigation System

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Official Source

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