Smith Associates
Country not established
- Devices
- 1
What Smith Associates makes
Smith Associates manufactures the SONALIS, a medical ultrasound imaging device designed for diagnostic imaging applications, including obstetrics, gynecology, and general abdominal scans.
The SONALIS is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Sonalis Ref K100204
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Smith Associates have in the registry?
The registry currently lists 1 device for Smith Associates. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smith Associates's devices?
Among its 1 most recently registered device, Smith Associates has devices listed in FDA 510(k) (1 device).
What risk classes do Smith Associates's devices fall under?
Among its 1 most recently registered device, the classes recorded for Smith Associates's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smith Associates in the registry?
The most recently registered devices listed for Smith Associates include SONALIS.