Saset (Chengdu), Inc.
ChinaFDA applicant, unverified
- Devices
- 2
What Saset (Chengdu), Inc. makes
Saset (Chengdu), Inc. manufactures diagnostic ultrasound systems, including the iNSIGHT Color Doppler Ultrasound System and the IMAGO C21 Diagnostic Ultrasound System. These devices are designed for medical imaging to visualize internal body structures and blood flow, supporting diagnostic evaluations in clinical settings.
The company’s ultrasound systems fall under FDA Class II regulation and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
iNSIGHT Color Doppler Ultrasound System Ref K150002
Regimes: 510(k) Registry: 510(k)Imago C21 Diagnostic Ultrasound System Ref K090059
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Saset (Chengdu), Inc. have in the registry?
The registry currently lists 2 devices for Saset (Chengdu), Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Saset (Chengdu), Inc.'s devices?
Among its 2 most recently registered devices, Saset (Chengdu), Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Saset (Chengdu), Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Saset (Chengdu), Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Saset (Chengdu), Inc. in the registry?
The most recently registered devices listed for Saset (Chengdu), Inc. include iNSIGHT Color Doppler Ultrasound System and IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM.