# K192703: Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Oct 8, 2020 after 377 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). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
2 of 19 devices in its family (counting itself) have 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 4.
- K070106: VV Fluoro 3D, Brainlab AG (2007) Summary page 4.

## Most influential descendants
- K223864: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial (2023), 1 descendant of its own
- K243698: Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (2025), 0 descendants of its own
- K223288: Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI (2023), 0 descendants of its own

## Indications for use
The Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is intended as an image-guided planning and navigation system to enable navigated surgery. It links instruments to a virtual computer image space on patient image data that is being processed by the navigation platform. 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, including: • Cranial Resection • Resection of tumors and other lesions • Resection of skull-base tumor or other lesions • AVM Resection • Cranial biopsies • Intracranial catheter placement • Intranasal structures and Paranasal Sinus Surgery • Functional endoscopic sinus surgery (FESS) • Revision & distorted anatomy surgery all intranasal structures and paranasal sinuses

Source page: https://510kreport.com/device/K192703
Methodology: https://510kreport.com/methodology