Beijing Infervision Healthcare Medical Technology Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3017489096
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Beijing Infervision Healthcare Medical Technology Co., Ltd. makes
Beijing Infervision Healthcare Medical Technology Co., Ltd. manufactures the InferOperate Suite and InferCare RECIST, which are medical software tools used for operative planning and RECIST-based response assessment.
Both products are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
InferOperate Suite Ref K260973
Regimes: 510(k) Registry: 510(k)InferOperate Suite Ref K250237
Regimes: CE MDR 510(k) Registry: 510(k)InferCare RECIST Ref K252261
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3017489096
- DUNS number
- 456657564
- Address
- Room 401, 4th Floor, Building 1, No.12, Shangdi Information Road, Haidian District, Beijing, China, Beijing
Frequently asked questions
How many devices does Beijing Infervision Healthcare Medical Technology Co., Ltd. have in the registry?
The registry currently lists 7 devices for Beijing Infervision Healthcare Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beijing Infervision Healthcare Medical Technology Co., Ltd.'s devices?
Among its 7 most recently registered devices, Beijing Infervision Healthcare Medical Technology Co., Ltd. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Beijing Infervision Healthcare Medical Technology Co., Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Beijing Infervision Healthcare Medical Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Beijing Infervision Healthcare Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Beijing Infervision Healthcare Medical Technology Co., Ltd. include InferRead CT Stroke.AI 1.1.1.1, InferCare RECIST 1.0.1.0, InferOperate Suite 1.1.0.1 and InferRead Lung CT.AI 5.0.3.6.