# K012719: Navigus II MR

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Oct 22, 2001 after 69 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100836: Clearpoint System (2010), 12 descendants of its own
- K111073: Surgivision Inc. Clearpoint System (2011), 11 descendants of its own
- K142505: ClearPoint System (2015), 10 descendants of its own
- K160434: ClearPoint System (2016), 9 descendants of its own
- K171257: ClearPoint System (2017), 8 descendants of its own

## Indications for use
Intended Use: The NAVIGUS II MR Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. This device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

Source page: https://510kreport.com/device/K012719
Methodology: https://510kreport.com/methodology