# K092467: Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial Unlimited

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: May 6, 2010 after 267 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983831 (1999). 8 ancestors in all.
10 later devices descend from it; 4 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082060: Cranial Image Guided Surgery System, Brainlab AG (2009) Summary page 3.

## Most influential descendants
- 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 (2020), 3 descendants of its own
- K171661: Scopis Extended Instrument Set EM (2017), 3 descendants of its own
- 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
- K193118: TGS Guidewire and updated Scopis Software (2020), 1 descendant of its own
- K231897: NeuroAlign software (2025), 0 descendants of its own

## Recalls of this device
- Aug 31, 2020 · Class II · Z-0056-2021: Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
- Apr 22, 2013 · Class I · Z-0598-2016: Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inac

## Indications for use
The Brainl-Al Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on patient image data being processed by the IGS workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-Ray, MR, MRA and ultrasound based model of the anatomy. Example procedures include but are not limited to: Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies! Craniectonijes Pediatric Catheter Shunt Placement General Catheter Shunt Placement Thalamotomies! Palliodotomies ENT Procedures: Transphenoidal procedures Maximillary antrostornies Ethmoidectomies Spheno-idotormes/ sphenoid explorations Turbinate resections Frontal sinusotomnies Intranasal

Source page: https://510kreport.com/device/K092467
Methodology: https://510kreport.com/methodology