Optimal Imaging Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Optimal Imaging Systems, Inc. makes
Optimal Imaging Systems, Inc. manufactures standalone diagnostic ultrasound systems, including the OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM and the OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM. These devices are designed for medical imaging to assist in diagnostic procedures across various clinical settings.
The company’s ultrasound systems fall under FDA Class II devices and are listed via the 510(k) pathway in the United States. The portfolio is regulated under US medical device authorities.
Catalogue
Ois-Stand Alone Diagnostic Ultrasound System Ref K000034
Regimes: 510(k) Registry: 510(k)Ois-2500 Diagnostic Ultrasound System Ref K000415
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optimal Imaging Systems, Inc. have in the registry?
The registry currently lists 2 devices for Optimal Imaging Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optimal Imaging Systems, Inc.'s devices?
Among its 2 most recently registered devices, Optimal Imaging Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Optimal Imaging Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Optimal Imaging Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optimal Imaging Systems, Inc. in the registry?
The most recently registered devices listed for Optimal Imaging Systems, Inc. include OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM and OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM.