510(k) · Cleared
ClearedNavivision
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 Sep 20, 2006 as substantially equivalent to K024192 (Brainlab AG, 2003) and 1 other predicate after a 61-day review. Its family tree reaches back 3 generations to 1999. 2 of the 86 devices in its family, counting itself, have a Class I recall. 77 later devices descend from it.
- Decided
- Sep 20, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K983831 (1999). 8 ancestors in all, the oldest K981508 (1998). 77 later devices descend from it, 2 citing it directly. 2 of the 86 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 2 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 1 generation backK042721 Kolibri SpineBrainlab AG · 2005
- This deviceK062086 NavivisionBrainlab AG · 2006
- 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 · 2 generations on · 35 of its ownK103152 6250 Ultrasound SytemsEsaote, S.p.A. · 2011
- Descendant · 2 generations on · 34 of its ownK133905 6200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 77 · 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
- K1031526250 Ultrasound SytemsEsaote, S.p.A. · 2011 · 2 generations on35descendants
- K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A. · 2014 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −2 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −1 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| 0 (this device) | K062086 | Navivision | Brainlab AG | 2006 | — |
| +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 | — |
| +2 | K103152 | 6250 Ultrasound Sytems | Esaote, S.p.A. | 2011 | — |
| +2 | K133905 | 6200 / 6250 Ultrasound System | Esaote, S.p.A. | 2014 | — |
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 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 1 |
| 2016 | 6 | 0 |
| 2017 | 8 | 1 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 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.
2 devices in this family have 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…NaviVision, BrainLAB Image Guided Surgery System Instrument, Stereotaxic Predicate Device: BrainLAB VectorVision fluoro " (K024192) BrainLAB Kolibri spine (K042721) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use:… | 2003 |
| * | K042721 | Kolibri SpineSummary page 1…ded Surgery System Instrument, Stereotaxic Predicate Device: BrainLAB VectorVision fluoro " (K024192) BrainLAB Kolibri spine (K042721) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use: Indications For Use: BrainLAB's… | 2005 |
What descends from it? (77)
See all 772 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 1 of the 8 ancestors has 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.
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's NaviVision is an add-on system for the Siemens mobile x-ray system Siemens Arcadis Orbic, including the 3D option Arcadis Orbic3D, and the Siemens mobile x-ray system Siemens Arcadis Varic. The NaviVision system 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…
Read the full statement (136 words)
BrainLAB's NaviVision is an add-on system for the Siemens mobile x-ray system Siemens Arcadis Orbic, including the 3D option Arcadis Orbic3D, and the Siemens mobile x-ray system Siemens Arcadis Varic. The NaviVision system 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 image data.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, for which imaging using the Siemens mobile x-ray system has been cleared, 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 and/or image data-based model of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062086: Navivision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062086
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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