Pacsgear, Inc.
Country not established
- Devices
- 1
What Pacsgear, Inc. makes
Pacsgear, Inc. manufactures Picture Archiving and Communication Systems (PACS) scanners, which are designed for digital imaging and storage in healthcare settings. These devices facilitate the acquisition, transmission, and display of medical images, enabling efficient workflows for radiology and diagnostic purposes.
The company’s PACS scanners fall under FDA Class II regulatory classification and are authorised through the 510(k) clearance process in the United States. The devices are listed in the FDA’s 510(k) registry, adhering to U.S. medical device regulations.
Catalogue
Pacs Scan Ref K083618
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pacsgear, Inc. have in the registry?
The registry currently lists 1 device for Pacsgear, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pacsgear, Inc.'s devices?
Among its 1 most recently registered device, Pacsgear, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Pacsgear, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Pacsgear, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pacsgear, Inc. in the registry?
The most recently registered devices listed for Pacsgear, Inc. include PACS SCAN.