# K944612: Acustar I Advanced Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Dec 11, 1995 after 448 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
83 later devices descend from it; 2 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960714: Isg Viewing Wand (1996), 71 descendants of its own
- K964229: Regulus Navigator (1997), 66 descendants of its own
- K981315: Navitrack (1998), 36 descendants of its own
- K033413: Spineassist Device (2004), 35 descendants of its own
- K051676: Spineassist Device with Additional Accessories (2005), 34 descendants of its own

Source page: https://510kreport.com/device/K944612
Methodology: https://510kreport.com/methodology