Augment Intelligent Medical System (China) Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3026309987
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Augment Intelligent Medical System (China) Co., Ltd. makes
The company manufactures navigation systems designed for minimally invasive prostate surgery, including the AmaKris SR1-A-2 model, which assists in precise surgical guidance during procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3026309987
- Address
- 1801-1812, Floor 18, Block B, Kechuang No.1 Building, No.320 Pubin Road, Jiangpu Sub-District, Pukou District, Nanjing Jiangsu
Frequently asked questions
How many devices does Augment Intelligent Medical System (China) Co., Ltd. have in the registry?
The registry currently lists 2 devices for Augment Intelligent Medical System (China) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Augment Intelligent Medical System (China) Co., Ltd.'s devices?
Among its 2 most recently registered devices, Augment Intelligent Medical System (China) Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Augment Intelligent Medical System (China) Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Augment Intelligent Medical System (China) Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Augment Intelligent Medical System (China) Co., Ltd. in the registry?
The most recently registered devices listed for Augment Intelligent Medical System (China) Co., Ltd. include Minimally Invasive Prostate Surgery Navigation System and Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2).