Augment Intelligent Medical System (China) Co., Ltd.
Registered establishment in Nanjing, Jiangsu, China. 1 device type, 2 clearances.
Augment Intelligent Medical System (China) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers System, Image Processing, Radiological. Its earliest product listing with the FDA dates from 2022.
1device type
2510(k) clearances
Registration
| Registered name | AUGMENT INTELLIGENT MEDICAL SYSTEM (CHINA) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3026309987 |
| FEI number | 3026309987 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 中奕智创医疗科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Nanjing |
|---|---|
| Province | Jiangsu |
| Address | 1801-1812, Floor 18, Block B, Kechuang No.1 Building, No.320 Pubin Road, Jiangpu Sub-District, Pukou District |
| Postal code | 210000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, Image Processing, Radiological | Class 2 | Minimally Invasive Prostate Surgery Navigation System (AmaKkris SR 1-A-2), Minimally Invasive Prostate Surgery Navigation System (AmaKkris SR 1-A-1) | 2022 | 16 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242314 | 2025-09-11 | LLZ | Traditional | This company |
| K221499 | 2022-11-22 | LLZ | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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