# K203679: Automatic Registration

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Mar 18, 2021 after 91 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: 7 generations back to K983831 (1999). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183605: Spine & Trauma Navigation, Brainlab AG (2019) Summary page 4.

## Most influential descendants
- K234047: Automatic Registration (2024), 0 descendants of its own

## Indications for use
Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

Source page: https://510kreport.com/device/K203679
Methodology: https://510kreport.com/methodology