Smartpacs
Country not established
- Devices
- 1
What Smartpacs makes
Smartpacs manufactures a filmless reading and image distribution system designed for medical imaging, enabling radiologists and clinicians to view, annotate, and share diagnostic images digitally. The system integrates with consultation stations to facilitate collaborative review and remote access to imaging studies.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Smartpacs have in the registry?
The registry currently lists 1 device for Smartpacs. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smartpacs's devices?
Among its 1 most recently registered device, Smartpacs has devices listed in FDA 510(k) (1 device).
What risk classes do Smartpacs's devices fall under?
Among its 1 most recently registered device, the classes recorded for Smartpacs's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smartpacs in the registry?
The most recently registered devices listed for Smartpacs include SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION.