Tomophase Corporation
Country not established
- Devices
- 1
What Tomophase Corporation makes
Tomophase Corporation manufactures the TOMOPHASE OCTIS, an optical coherence tomography intravascular imaging system designed for coronary and peripheral vascular assessments. This device provides cross-sectional imaging of blood vessels to support diagnostic procedures in interventional cardiology.
The TOMOPHASE OCTIS is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Tomophase Octis Ref K102599
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tomophase Corporation have in the registry?
The registry currently lists 1 device for Tomophase Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tomophase Corporation's devices?
Among its 1 most recently registered device, Tomophase Corporation has devices listed in FDA 510(k) (1 device).
What risk classes do Tomophase Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Tomophase Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tomophase Corporation in the registry?
The most recently registered devices listed for Tomophase Corporation include TOMOPHASE OCTIS.