510(k) · Cleared
ClearedCranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
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 Oct 8, 2020 as substantially equivalent to K092467 (Brainlab AG, 2010) and 1 other predicate after a 377-day review. Its family tree reaches back 5 generations to 1999. 2 of the 19 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Oct 8, 2020
- Review
- 377 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K983831 (1999). 15 ancestors in all, the oldest K981508 (1998). 3 later devices descend from it, 2 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 4 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 3 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 2 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 1 generation backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- This deviceK192703 Cranial Image Guided Surgery System, Navigation Software Cranial…Brainlab AG · 2020
- Descendant · cites it directly · 1 of its ownK223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment…Brainlab AG · 2023
- Descendant · 2 generations on · 0 of its ownK243698 Alignment System Cranial, with Alignment Software Cranial with LITT…Brainlab AG · 2025
- Descendant · cites it directly · 0 of its ownK223288 Cranial Navigation, Navigation Software Cranial, Navigation Software…Brainlab AG · 2023
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG · 2023 · cites it directly1descendant
- K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG · 2025 · 2 generations on0descendants
- K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −4 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −3 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −2 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −1 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| 0 (this device) | K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation… | Brainlab AG | 2020 | — |
| +1 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software… | Brainlab AG | 2023 | — |
| +2 | K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq… | Brainlab AG | 2025 | — |
| +1 | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software… | Brainlab AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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.
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 |
|---|---|---|---|
| * | K092467 | Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Summary page 4…assification Product Code HAW Review Panel: Neurology Device Class: Class II Primary Predicate Device: K092467, Cranial Image Guided Surgery System, by Brainlab AG Secondary Predicate Device: K070106, VectorVision Fluoro 3D, by B… | 2010 |
| * | K070106 | VV Fluoro 3DSummary page 4…ss: Class II Primary Predicate Device: K092467, Cranial Image Guided Surgery System, by Brainlab AG Secondary Predicate Device: K070106, VectorVision Fluoro 3D, by Brainlab AG K192703 Page 2 of 7 CONTACT INFO… | 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? (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.
- K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial UnlimitedBrainlab AG · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K070106VV Fluoro 3DBrainlab AG · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 5 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K223864 (Brainlab AG, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K092467.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is intended as an image-guided planning and navigation system to enable navigated surgery. It links instruments to a virtual computer image space on patient image data that is being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified…
Read the full statement (136 words)
The Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is
intended as an image-guided planning and navigation system to enable navigated surgery. It links instruments to a virtual
computer image space on patient image data that is being processed by the navigation platform.
The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified
relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, including:
• Cranial Resection
• Resection of tumors and other lesions
• Resection of skull-base tumor or other lesions
• AVM Resection
• Cranial biopsies
• Intracranial catheter placement
• Intranasal structures and Paranasal Sinus Surgery
• Functional endoscopic sinus surgery (FESS)
• Revision & distorted anatomy surgery all intranasal structures and paranasal sinuses
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192703: Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192703
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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