Image-Guided Neurologics, Inc.
United StatesFDA applicant, unverified
- Devices
- 22
What Image-Guided Neurologics, Inc. makes
Image-Guided Neurologics, Inc. manufactures surgical guidance tools for neurosurgical procedures, including reusable passive probes, trajectory guides, fiducial marker systems, and cranial drilling instruments. Their portfolio includes MRI-compatible navigation aids like the Navigus II MR, aspiration/irrigation catheters, peel-away introducers, and accessories such as burr hole covers. These devices assist in precise stereotactic and minimally invasive neurosurgeries by enhancing spatial orientation and reducing procedural errors.
The company’s products are classified under Class II medical devices in the US and are listed in the FDA 510(k) registry. The portfolio is regulated under the US Food and Drug Administration (FDA) standards, with individual devices subject to premarket notification (510(k)) clearance. The manufacturer is based in the United States.
Catalogue
Search and filter all 22 devicesFrequently asked questions
How many devices does Image-Guided Neurologics, Inc. have in the registry?
The registry currently lists 22 devices for Image-Guided Neurologics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Image-Guided Neurologics, Inc.'s devices?
Among its 22 most recently registered devices, Image-Guided Neurologics, Inc. has devices listed in FDA 510(k) (22 devices).
What risk classes do Image-Guided Neurologics, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Image-Guided Neurologics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Image-Guided Neurologics, Inc. in the registry?
The most recently registered devices listed for Image-Guided Neurologics, Inc. include TRAJECTORY GUIDE, MODEL # TGX-XXX, NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000, NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 and REMOTE INTRODUCER, MODEL PI-1000.