Xonics Medical Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Xonics Medical Systems, Inc. makes
Xonics Medical Systems, Inc. manufactures diagnostic ultrasound systems, including the IC 3000 model, and X-ray generators for mammographic imaging under the ESP series. These devices are designed for medical imaging purposes, including ultrasound-based diagnostics and X-ray mammography.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with products listed via the 510(k) pathway. These devices are registered in the United States.
Catalogue
Model Ic 3000 Ref K827292
510(k) 510(k)Diagnostic Ultrasound System Ref K791298
510(k) 510(k)Esp Series (X-Ray Generators Ref K820593
510(k) 510(k)X-Ray Device, Mammographic Diagnostic Ref K770693
510(k) 510(k)
Frequently asked questions
How many devices does Xonics Medical Systems, Inc. have in the registry?
The registry currently lists 4 devices for Xonics Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xonics Medical Systems, Inc.'s devices?
Among its 4 most recently registered devices, Xonics Medical Systems, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Xonics Medical Systems, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Xonics Medical Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xonics Medical Systems, Inc. in the registry?
The most recently registered devices listed for Xonics Medical Systems, Inc. include MODEL IC 3000, DIAGNOSTIC ULTRASOUND SYSTEM, ESP SERIES (X-RAY GENERATORS and X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC.