Surgical Insights, Inc.
Country not established
- Devices
- 1
What Surgical Insights, Inc. makes
Surgical Insights, Inc. manufactures the INSIGHT Image Guided Surgical System, a device designed to provide real-time imaging and navigation support during surgical procedures for enhanced precision and safety.
The company’s portfolio is regulated under FDA Class II devices, with the INSIGHT Image Guided Surgical System authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Insight Image Guided Surgical System Ref K001642
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Surgical Insights, Inc. have in the registry?
The registry currently lists 1 device for Surgical Insights, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgical Insights, Inc.'s devices?
Among its 1 most recently registered device, Surgical Insights, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Surgical Insights, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Surgical Insights, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgical Insights, Inc. in the registry?
The most recently registered devices listed for Surgical Insights, Inc. include INSIGHT IMAGE GUIDED SURGICAL SYSTEM.