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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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Augment Intelligent Medical System (China) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221499Minimally Invasive Prostate Surgery Navigation System

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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