# K070106: VV Fluoro 3D - Pathway: 510(k) (Traditional) - Applicant: Brainlab AG - Decided: Apr 23, 2007 after 102 days - Product code: HAW (Neurological Stereotaxic Instrument) - Device class: 2 - Regulation: 21 CFR 882.4560 - Recalls of this device: 5 (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). 9 ancestors in all. 119 later devices descend from it; 10 cite it directly. 1 of 129 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K024192: Vectorvision FLUORO3D, Brainlab AG (2003) Summary page 1. - K053159: Vectorvision Spine, Brainlab AG (2006) Summary page 1. ## 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 - K083310: Spine & Trauma Ict (2009), 40 descendants of its own - K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own ## Recalls of this device - Feb 27, 2019 · Class I · Z-1082-2019: In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the - Nov 16, 2017 · Class II · Z-0320-2018: Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specification - May 8, 2015 · Class II · Z-0282-2016: Instances of data sets not being accurately registered to the patient anatomy were observed. - May 21, 2014 · Class II · Z-2213-2014: Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the ga - Nov 18, 2013 · Class II · Z-1469-2014: The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoros ## Indications for use BrainLAB VectorVision fluoro3D is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. VectorVision fluoro3D enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools. 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, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. Source page: https://510kreport.com/device/K070106 Methodology: https://510kreport.com/methodology