# K234047: Automatic Registration

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Mar 20, 2024 after 90 days
- Product code: OLO (Orthopedic 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: 8 generations back to K983831 (1999). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203679: Automatic Registration, Brainlab AG (2021) Summary page 4.

## Indications for use
Automatic Registration is a software device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems such as the Brainlab Spine & Trauma Navigation System. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images.

Source page: https://510kreport.com/device/K234047
Methodology: https://510kreport.com/methodology