# Image-Guided Neurologics, Inc.

- Location (FDA's records): Melbourne, FL
- FDA decisions: 22 (1999–2005): 22 510(k) clearances
- Product codes: HAW (15), LNH (1), GWG (1), GXR (1), MOS (1), HBB (1), HCA (1), HBL (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- ClearPoint Neuro, Inc.: 3 (https://510kreport.com/company/clearpoint-neuro)
- Monteris Medical,: 2 (https://510kreport.com/company/monteris-medical)
- Medtronic Navigation, Inc.: 2 (https://510kreport.com/company/medtronic-navigation)
- NeuroPace, Inc.: 1 (https://510kreport.com/company/neuropace)
- Surgivision, Inc.: 1 (https://510kreport.com/company/surgivision)
- Phasor Health, LLC: 1 (https://510kreport.com/company/phasor-health)

## Its most-cited devices
- K012366: Navigus II Trajectory Guide (2001), cited by 3
- K033619: Navigus Unibody Fiducial Marker System, Model FM-4000 (2004), cited by 2
- K992304: Navigus Trajectory Guide, Model TG-XXXX (1999), cited by 2
- K040334: Navigus Passive Probe, Model NP-1000 (2004), cited by 1
- K001096: Burr Hole Cover, Model XX (2000), cited by 1
- K012719: Navigus II MR (2001), cited by 1

## Recent decisions
- K050772: Navigus Reusable Passive Probe, Model SP-2000 (Apr 21, 2005)
- K043091: Navigus Nexdrive, Model MI-3000 (Feb 7, 2005)
- K040334: Navigus Passive Probe, Model NP-1000 (Oct 4, 2004)
- K040834: Navigus Passive Probe (BL), Model NP-2000 (Jun 3, 2004)
- K033619: Navigus Unibody Fiducial Marker System, Model FM-4000 (Mar 2, 2004)
- K031885: Navigus Passive Head Restraint System, Model HR-XXX (Aug 21, 2003)
- K024201: Navigus Fiducial Marker System, Models FM-1000, FM-2000 (Mar 12, 2003)
- K023949: Navigus II Trajectory Guide with Verification Reticules (Feb 25, 2003)

Source page: https://510kreport.com/company/image-guided-neurologics