# K190250: Microscope Navigation

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Sep 6, 2019 after 211 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.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172820: Microscope Navigation Software, Brainlab AG (2018) Summary page 4.
- K082060: Cranial Image Guided Surgery System, Brainlab AG (2009) Summary page 5.

## Indications for use
The Brainlab Navigation System – Microscope Navigation Software is a software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery. It links an instrument and the view of the surgical field (e.g., video, view through surgical microscope) to a virtual computer image space on patient image data being processed by the navigation workstation. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy.

Source page: https://510kreport.com/device/K190250
Methodology: https://510kreport.com/methodology