510(k) · Cleared
Recalled · Class I · 2019VV Fluoro 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Apr 23, 2007 as substantially equivalent to K024192 (Brainlab AG, 2003) and 1 other predicate after a 102-day review. Its family tree reaches back 4 generations to 1999. 1 of the 129 devices in its family, counting itself, has a Class I recall. 119 later devices descend from it. It has been recalled 5 times, including a Class I recall.
- Decided
- Apr 23, 2007
- Review
- 102 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 5 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K983831 (1999). 9 ancestors in all, the oldest K981508 (1998). 119 later devices descend from it, 10 citing it directly. 1 of the 129 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 3 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 2 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 1 generation backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- This deviceK070106 VV Fluoro 3DBrainlab AG · 2007
- Descendant · cites it directly · 53 of its ownK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · Recalled
- Descendant · 2 generations on · 51 of its ownK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- Descendant · 2 generations on · 46 of its ownK100931 Mylabtwice, Model 6200Esaote, S.p.A. · 2010
- Descendant · cites it directly · 40 of its ownK083310 Spine & Trauma IctBrainlab AG · 2009
- Descendant · 2 generations on · 35 of its ownK103152 6250 Ultrasound SytemsEsaote, S.p.A. · 2011
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · cites it directly53descendants
- K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A. · 2009 · 2 generations on51descendants
- K100931Mylabtwice, Model 6200Esaote, S.p.A. · 2010 · 2 generations on46descendants
- K083310Spine & Trauma IctBrainlab AG · 2009 · cites it directly40descendants
- K1031526250 Ultrasound SytemsEsaote, S.p.A. · 2011 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −3 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −2 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −1 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| 0 (this device) | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | — |
| +1 | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | Esaote, S.p.A. | 2008 | 2 |
| +2 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| +2 | K100931 | Mylabtwice, Model 6200 | Esaote, S.p.A. | 2010 | — |
| +1 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| +2 | K103152 | 6250 Ultrasound Sytems | Esaote, S.p.A. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 13 | 0 |
| 2020 | 9 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 15 | 0 |
| 2025 | 10 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024192 | Vectorvision FLUORO3DSummary page 1…ctorVisibn fluoro 3D Common/Classification Name: BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Device: VectorVision fluoro 3D (K024192) VectorVision spine (K053159). Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use: Brai… | 2003 |
| * | K053159 | Vectorvision SpineSummary page 1…lassification Name: BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Device: VectorVision fluoro 3D (K024192) VectorVision spine (K053159). Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use: BrainLAB VectorVision fluoro3D is… | 2006 |
What descends from it? (119)
See all 11910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | 2008 | 53 |
| K083310 | Spine & Trauma Ict | 2009 | 40 |
| K122211 | Synthes Navigable Pedicle Preparation Instruments | 2012 | 20 |
| K130887 | S4C Navigation Instruments | 2013 | 13 |
| K162921 | Navigated Instrument System | 2017 | 5 |
| K172115 | Navigated Instrument System | 2018 | 4 |
| K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software… | 2020 | 3 |
| K120867 | Viper and Expedium Navigated Instruments | 2012 | 2 |
| K140927 | Universal Navigation Instruments | 2014 | 1 |
| K191285 | Spine & Trauma Navigation | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2019 | Class I | Z-1082-2019 | Software design | 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 image reconstruction (the not-updated… |
| Nov 16, 2017 | Class II | Z-0320-2018 | Nonconforming Material/Component | 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 specifications. |
| May 8, 2015 | Class II | Z-0282-2016 | Nonconforming Material/Component | Instances of data sets not being accurately registered to the patient anatomy were observed. |
| May 21, 2014 | Class II | Z-2213-2014 | Software in the Use Environment | 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 gantry position of the scanner. The… |
| Nov 18, 2013 | Class II | Z-1469-2014 | Software design | 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 fluoroscopic images, used by the navigation… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K081386 (Esaote, S.p.A., 2008) has gone furthest, with 53 descendants of its own.
- 1 other device also cites its predicate K024192.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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…
Read the full statement (152 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070106: VV Fluoro 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070106
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026