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510(k) K221499

Minimally Invasive Prostate Surgery Navigation System by Augment Intelligent Medical System (China) Co., Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2022
Date Received
May 23, 2022
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.

  • K242314 — Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) (September 11, 2025)

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