Genesis Digital Imaging, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Genesis Digital Imaging, Inc. makes
Genesis Digital Imaging, Inc. manufactures digital imaging systems, including the OMNI-VUE 2 SYSTEM and OMNI-VUE SYSTEM, designed for medical imaging applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Omni-Vue 2 System Ref K130374
Regimes: 510(k) Registry: 510(k)Omni-Vue System Ref K073062
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genesis Digital Imaging, Inc. have in the registry?
The registry currently lists 2 devices for Genesis Digital Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genesis Digital Imaging, Inc.'s devices?
Among its 2 most recently registered devices, Genesis Digital Imaging, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Genesis Digital Imaging, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Genesis Digital Imaging, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genesis Digital Imaging, Inc. in the registry?
The most recently registered devices listed for Genesis Digital Imaging, Inc. include OMNI-VUE 2 SYSTEM and OMNI-VUE SYSTEM.