Softlink International Private Limited
IndiaFDA applicant, unverified
- Devices
- 1
What Softlink International Private Limited makes
Softlink International Private Limited develops the Imagine® Enterprise Suite, a software platform designed for medical imaging management and workflow optimization in healthcare settings. This includes tools for picture archiving and communication systems (PACS), radiology information systems (RIS), and integration with diagnostic imaging equipment to streamline radiology operations.
The company’s portfolio is regulated under Class II medical devices in the United States, with relevant products authorised through the FDA’s 510(k) clearance process. The company is based in the US, and its products are listed in the FDA’s 510(k) database.
Catalogue
Imagine® Enterprise Suite Ref K252634
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Softlink International Private Limited have in the registry?
The registry currently lists 1 device for Softlink International Private Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Softlink International Private Limited's devices?
Among its 1 most recently registered device, Softlink International Private Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Softlink International Private Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Softlink International Private Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Softlink International Private Limited in the registry?
The most recently registered devices listed for Softlink International Private Limited include Imagine® Enterprise Suite.