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510(k) K242314

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2025
Date Received
August 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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

  • K221499 — Minimally Invasive Prostate Surgery Navigation System (November 22, 2022)

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