Raysolution Healthcare Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 1
What Raysolution Healthcare Co., Ltd. makes
Raysolution Healthcare Co., Ltd. manufactures a hybrid imaging system combining positron emission tomography (PET) with X-ray computed tomography (CT), branded as the DigitMI 930. This device integrates metabolic and anatomical imaging to support diagnostic evaluations in oncology and other medical specialties.
The company’s portfolio is regulated under Class II devices in the US, with the DigitMI 930 authorised via the FDA’s 510(k) pathway. The system is listed in the FDA’s 510(k) database, adhering to US medical device regulations. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Raysolution Healthcare Co., Ltd. have in the registry?
The registry currently lists 1 device for Raysolution Healthcare Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Raysolution Healthcare Co., Ltd.'s devices?
Among its 1 most recently registered device, Raysolution Healthcare Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Raysolution Healthcare Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Raysolution Healthcare Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Raysolution Healthcare Co., Ltd. in the registry?
The most recently registered devices listed for Raysolution Healthcare Co., Ltd. include Imaging system of positron emission and X-ray computed tomography (DigitMI 930).