Neusoft Positron Medical Systems Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Neusoft Positron Medical Systems Co., Ltd. makes
Neusoft Positron Medical Systems manufactures positron emission tomography (PET) scanners, including the ATTRIUS (models PET150A6001 and PET150A8001), ATTRIUS L (model PET150A8001), and TRUESIGHT (models NSP-P6C and NSP-P8). These devices are designed for imaging metabolic processes in the body, primarily used in oncology, neurology, and cardiology diagnostics.
The company’s PET scanners fall under Class II regulatory classification in the US, requiring 510(k) clearance through the FDA. These devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model Nsp-P6C, Truesight, Model Nsp-P8 Ref K090178
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Neusoft Positron Medical Systems Co., Ltd. Shen Yang Liaoning · CN FEI 3007675950
Frequently asked questions
How many devices does Neusoft Positron Medical Systems Co., Ltd. have in the registry?
The registry currently lists 1 device for Neusoft Positron Medical Systems Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neusoft Positron Medical Systems Co., Ltd.'s devices?
Among its 1 most recently registered device, Neusoft Positron Medical Systems Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Neusoft Positron Medical Systems Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Neusoft Positron Medical Systems Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neusoft Positron Medical Systems Co., Ltd. in the registry?
The most recently registered devices listed for Neusoft Positron Medical Systems Co., Ltd. include ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8.
Which FDA establishments are linked to Neusoft Positron Medical Systems Co., Ltd.?
1 FDA establishment is linked to Neusoft Positron Medical Systems Co., Ltd. in the registry; they are listed on the company page.