Biosound, Inc.
United StatesFDA applicant, unverified
- Devices
- 39
What Biosound, Inc. makes
Biosound, Inc. manufactures diagnostic ultrasound transducers, including intracavity and biopsy accessories, as well as ultrasound imaging systems like the 7050. Their portfolio also includes electrophysiological devices such as the Galileo line (Planet 100, 200, 300, and Star), the Galileo Vega-24 electroencephalograph, and evoked potential systems. Additional offerings include topographic brain mapping options, transcranial probes, and firmware for electrocardiograph stress tests.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) clearance registry. Products are listed under U.S. jurisdiction, adhering to U.S. medical device compliance standards.
Catalogue
Search and filter all 39 devicesFrequently asked questions
How many devices does Biosound, Inc. have in the registry?
The registry currently lists 39 devices for Biosound, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosound, Inc.'s devices?
Among its 39 most recently registered devices, Biosound, Inc. has devices listed in FDA 510(k) (39 devices).
What risk classes do Biosound, Inc.'s devices fall under?
Among its 39 most recently registered devices, the classes recorded for Biosound, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosound, Inc. in the registry?
The most recently registered devices listed for Biosound, Inc. include DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A, THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR, ARTOSCAN and TOPOGRAPHIC BRAIN MAPPING OPTION.