MRI Interventions, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
What MRI Interventions, Inc. makes
Mri Interventions, Inc. manufactures medical devices for neurosurgical and interventional procedures, including stereotactic systems like the ClearPoint System and Arcus Head Fixation Frame for precise brain targeting. Their portfolio also includes MRI-compatible drilling tools such as the SmartTwist MRII Hand Drill and drill bit kits, as well as trajectory guidance systems like the Voyager Trajectory Array Guide (V-TAG). Additional offerings include aspiration kits, cranial drilling accessories, and specialized catheters like the SMARTFLOW Catheter for intraoperative use.
The company’s devices are classified under Class II by the FDA and are authorised through the 510(k) clearance pathway. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance for use in the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Mri Interventions, Inc. have in the registry?
The registry currently lists 14 devices for Mri Interventions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mri Interventions, Inc.'s devices?
Among its 14 most recently registered devices, Mri Interventions, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Mri Interventions, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Mri Interventions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mri Interventions, Inc. in the registry?
The most recently registered devices listed for Mri Interventions, Inc. include ClearPoint System and Accessories, Arcus Head Fixation Frame, ClearPoint System and VARIOGUIDE DRILL KIT.