Dr Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Dr Systems, Inc. makes
Dr Systems, Inc. develops and maintains Picture Archiving and Communication Systems (PACS), including DR Systems PACS, Release 6.1, a software solution for managing and distributing medical imaging data. The company also provides 3D medical imaging viewers, such as the Zero Download 3D Viewer (Z3D), designed for remote visualization of volumetric imaging without requiring local software installation.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Dr Systems Pacs, Release 6.1 Ref K041935
510(k) 510(k)DR Systems Zero Download 3D Viewer (Z3D) Ref K143318
510(k) 510(k)
Frequently asked questions
How many devices does Dr Systems, Inc. have in the registry?
The registry currently lists 2 devices for Dr Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dr Systems, Inc.'s devices?
Among its 2 most recently registered devices, Dr Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dr Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dr Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dr Systems, Inc. in the registry?
The most recently registered devices listed for Dr Systems, Inc. include DR SYSTEMS PACS, RELEASE 6.1 and DR Systems Zero Download 3D Viewer (Z3D).