# K213989: Cranial EM System

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Sep 8, 2022 after 262 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 K050438 (2005). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201175: StealthStation Cranial Software v1.3.0, Medtronic Navigation, Inc. (2020) Summary page 4.
- K042391: Kolibri Image Guided Surgery System, Brainlab AG (2004) Summary page 4.

## Most influential descendants
- K223288: Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI (2023), 0 descendants of its own

## Indications for use
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device 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, such as: * Cranial Resection o Resection of tumors and other lesions o Resection of skull-base tumor or other lesions * Intracranial catheter placement

Source page: https://510kreport.com/device/K213989
Methodology: https://510kreport.com/methodology