Dome Imaging Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Dome Imaging Systems, Inc. makes
Dome Imaging Systems, Inc. manufactures the PACSCACHE, a system for managing and archiving medical imaging data, and the DOME CX Digital Flat-Panel Display System (Model C5I), a high-resolution display designed for radiology and diagnostic imaging workflows.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Pacscache Ref K983815
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Dome Imaging Systems, Inc. have in the registry?
The registry currently lists 2 devices for Dome Imaging Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dome Imaging Systems, Inc.'s devices?
Among its 2 most recently registered devices, Dome Imaging Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dome Imaging Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dome Imaging Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dome Imaging Systems, Inc. in the registry?
The most recently registered devices listed for Dome Imaging Systems, Inc. include PACSCACHE and DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I.