# K231897: NeuroAlign software

- Pathway: 510(k) (Traditional)
- Applicant: Medivis, Inc.
- Decided: Oct 21, 2025 after 846 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
Longest line of descent: 5 generations back to K983831 (1999). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092467: Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial Unlimited, Brainlab AG (2010) Summary page 5.

## Indications for use
The Medivis NeuroAlign device is stereotaxic image guidance system intended to be used with the Microsoft HoloLens headset for the spatial positioning and orientation of neurosurgical instruments employed by surgeons. This device is specifically intended for cranial surgery, where reference to a rigid anatomical structure can be identified, without the need for a frame or fixation of a navigated instrument guide to the patient. The system is intended for use in various surgical settings, including operating rooms, intensive care units, and interventional procedure suites.

Source page: https://510kreport.com/device/K231897
Methodology: https://510kreport.com/methodology