510(k) · Cleared
ClearedModification to: Vectorvision Frameless Biopsy System
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 6, 2001 as substantially equivalent to K983831 (Brainlab AG, 1999) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1999. 55 later devices descend from it.
- Decided
- Sep 6, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983831 (1999). 2 ancestors in all. 55 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983831 VECTORVISION2Brainlab AG · 1999
- This deviceK012564 Modification to: Vectorvision Frameless Biopsy SystemBrainlab AG · 2001
- 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 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · 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 |
|---|---|---|---|---|---|
| −1 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| 0 (this device) | K012564 | Modification to: Vectorvision Frameless Biopsy System | Brainlab AG | 2001 | — |
| +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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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.
Planning a device in HAW? 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 |
|---|---|---|---|
| * | K983831 | VECTORVISION2Summary page 2…by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of BrainLAB's VectorVision? System (K983831, KO03589). AERVT, & y‘“d BEALTY é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service erq Food and Dru… | 1999 |
| * | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent | 2001 |
What descends from it? (55)
See all 552 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
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…
Read the full statement (154 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012564: Modification to: Vectorvision Frameless Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012564
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026