Data / Medical devices / China / Augment Intelligent Medical System (china) Co., Ltd.
Augment Intelligent Medical System (china) Co., Ltd.: FDA-registered device maker in Nanjing Jiangsu, China, 2 510(k) clearances
Augment Intelligent Medical System (china) Co., Ltd. is registered with the FDA (registration 3026309987) in Nanjing Jiangsu, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026309987
- Address
- 1801-1812, Floor 18, Block B, Kechuang No.1 Building, No.320 Pubin Road, Jiangpu Sub-District, Pukou District, Nanjing Jiangsu, China, 210000
- Owner or operator
- Augment Intelligent Medical System (China) Co., Ltd. (10086934)
- Roles
- Manufacturer
- First device listed
- December 23, 2022
- Registered through
- 2026
- Brand names listed
- Minimally Invasive Prostate Surgery Navigation System (AmaKkris SR 1-A-1), Minimally Invasive Prostate Surgery Navigation System (AmaKkris SR 1-A-2)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2025 | K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | LLZ | Substantially Equivalent | Augment Intelligent Medical System (China) Co., Ltd. | accessdata.fda.gov |
| November 22, 2022 | K221499 | Minimally Invasive Prostate Surgery Navigation System | LLZ | Substantially Equivalent | Augment Intelligent Medical System (China) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.