Class Class II

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) (K242314)

K242314 2025-09-11 Traditional
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Description

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) by Augment Intelligent Medical System (China) Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242314
Clearance Date2025-09-11
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050

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