# K012564: Modification to: Vectorvision Frameless Biopsy System

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Sep 6, 2001 after 28 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: 1 generation back to K983831 (1999). 2 ancestors in all.
55 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 2.
- K003589: Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent, Brainlab AG (2001)

## Most influential descendants
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90) (2008), 53 descendants of its own
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own
- K100931: Mylabtwice, Model 6200 (2010), 46 descendants of its own
- K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own

## Indications for use
The BrainLAB VectorVision Frameless Biopsy System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a frechand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s preoperative image data being processed by a Vector Vision workstation. The system is indicated for any medical condition in which fhe uge 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, X-ray or MR based model of the anatomy. Example procedures include but are not limited to: Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies. Spinal Procedures: Spinal implant procedures such as pedicle screw placement. ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/ Sphenoid explorations, Turbinate resections and Frontal sinusotomies

Source page: https://510kreport.com/device/K012564
Methodology: https://510kreport.com/methodology