510(k) · Cleared
ClearedSonowand Invite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonowand AS · HAW Neurological Stereotaxic Instrument
Cleared on Sep 25, 2009 as substantially equivalent to K023651 (Brainlab AG, 2004) and 2 other predicates after a 294-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 25, 2009
- Review
- 294 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K935595 (1995). 31 ancestors in all, the oldest K921148 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations between
- 3 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK072365 Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- This deviceK083597 Sonowand InviteSonowand AS · 2009
- Descendant · cites it directly · 2 of its ownK112469 General Prupose Localizers and Adapters-New Accessories for Sonowand…Sonowand AS · 2012
- Descendant · cites it directly · 1 of its ownK203251 SOLOPASS SystemIntravent Medical Partners, LP · 2021
- Descendant · 2 generations on · 0 of its ownK251317 SOLOPASS 2.0 SystemIntravent Medical Partners · 2025
Show all 9 generations
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 7 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 6 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 5 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 3 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK072365 Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- This deviceK083597 Sonowand InviteSonowand AS · 2009
Most influential descendants
Showing 3 of 3 · See all- K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS · 2012 · cites it directly2descendants
- K203251SOLOPASS SystemIntravent Medical Partners, LP · 2021 · cites it directly1descendant
- K251317SOLOPASS 2.0 SystemIntravent Medical Partners · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −8 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −7 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −6 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −5 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −3 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −1 | K072365 | Sequoia Plus Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 3 |
| 0 (this device) | K083597 | Sonowand Invite | Sonowand AS | 2009 | — |
| +1 | K112469 | General Prupose Localizers and Adapters-New Accessories for Sonowand System | Sonowand AS | 2012 | — |
| +1 | K203251 | SOLOPASS System | Intravent Medical Partners, LP | 2021 | — |
| +2 | K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K023651 | Vectorvision Cranial/EntSummary page 1…08 Device Name and Classification: SonoWand® Invite, Class II 21 CFR 882.4560, 892.1550 Product Code HAW, IYN Equivalent Device Identification: BrainLab Vector Vision (K023651), GE Vivid-I (K061525), Seimens Sequoia™ Plus (K072365) Device Description: Invite is an integrated neuronavigation system with… | 2004 |
| * | K061525 | GE Vivid - ISummary page 1…assification: SonoWand® Invite, Class II 21 CFR 882.4560, 892.1550 Product Code HAW, IYN Equivalent Device Identification: BrainLab Vector Vision (K023651), GE Vivid-I (K061525), Seimens Sequoia™ Plus (K072365) Device Description: Invite is an integrated neuronavigation system with intraoperative imagin… | 2006 |
| * | K072365 | Sequoia Plus Diagnostic Ultrasound SystemSummary page 1…lass II 21 CFR 882.4560, 892.1550 Product Code HAW, IYN Equivalent Device Identification: BrainLab Vector Vision (K023651), GE Vivid-I (K061525), Seimens Sequoia™ Plus (K072365) Device Description: Invite is an integrated neuronavigation system with intraoperative imaging capabilities. The main componen… | 2007 |
What descends from it? (3)
2 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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 8 of the 31 ancestors have a recall of any class.
- Of its descendants, K112469 (Sonowand AS, 2012) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K023651.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Sonowand is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. The Sonowand is intended for use as a standard neuronavigation system. The Sonowand is intended for use as a stand-alone ultrasound scanner.
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/K083597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083597: Sonowand Invite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083597
Report an extraction error
Are you the manufacturer?
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