Zonare Medical Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 28
What Zonare Medical Systems, Inc. makes
Zonare Medical Systems, Inc. manufactures diagnostic ultrasound systems, including the ZS3, Z.One Ultra, and Ultra models, designed for medical imaging applications. These systems are intended for general diagnostic use, supporting real-time imaging of internal body structures such as organs, tissues, and blood flow.
The company’s ultrasound systems are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where they are subject to compliance with FDA requirements for diagnostic ultrasound equipment.
Catalogue
Search and filter all 28 devicesCompany details
- DUNS number
- 096113340
Frequently asked questions
How many devices does ZONARE MEDICAL SYSTEMS, INC. have in the registry?
The registry currently lists 28 devices for ZONARE MEDICAL SYSTEMS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ZONARE MEDICAL SYSTEMS, INC.'s devices?
Among its 28 most recently registered devices, ZONARE MEDICAL SYSTEMS, INC. has devices listed in FDA 510(k) (6 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ZONARE MEDICAL SYSTEMS, INC.'s devices fall under?
Among its 28 most recently registered devices, the classes recorded for ZONARE MEDICAL SYSTEMS, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ZONARE MEDICAL SYSTEMS, INC. in the registry?
The most recently registered devices listed for ZONARE MEDICAL SYSTEMS, INC. include C9-3 Curved Array Transducer, E9-3 3D Curved Array Transducer, A5CW Continuous Wave Transducer and L8-3 Linear Array Transducer.