Stereotactic Image Systems, Inc.
Country not established
- Devices
- 1
What Stereotactic Image Systems, Inc. makes
Stereotactic Image Systems, Inc. develops stereotactic medical application software, designed for precision-guided imaging and treatment planning in surgical procedures, particularly in neurosurgery and radiation oncology.
The company’s portfolio is regulated under FDA Class II devices and includes products authorised via 510(k) clearance. The software is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Stereotactic One Medical Application Software Ref K901883
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stereotactic Image Systems, Inc. have in the registry?
The registry currently lists 1 device for Stereotactic Image Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stereotactic Image Systems, Inc.'s devices?
Among its 1 most recently registered device, Stereotactic Image Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Stereotactic Image Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Stereotactic Image Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stereotactic Image Systems, Inc. in the registry?
The most recently registered devices listed for Stereotactic Image Systems, Inc. include STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE.