510(k) · Cleared
ClearedAdvantage Windows 3D with Navigator Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Nov 14, 1995 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 759 devices in its family, counting itself, has a Class I recall. 758 later devices descend from it.
- Decided
- Nov 14, 1995
- Review
- 57 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
758 later devices descend from it, 10 citing it directly. 1 of the 759 devices in this family, counting this one, has a Class I recall.
- This deviceK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- Descendant · cites it directly · 580 of its ownK012313 CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 2001 · Recalled
- Descendant · cites it directly · 516 of its ownK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 469 of its ownK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
- Descendant · cites it directly · 298 of its ownK974715 Advantage 3D XRGE Medical Systems · 1998
- Descendant · 2 generations on · 245 of its ownK984634 3D-AngioSiemens Medical Corp. · 1999
Showing 5 of 758 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 758 · See all- K012313CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 2001 · cites it directly580descendants
- K972399Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · cites it directly516descendants
- K041521Volume Viewer PlusGeneral Electric Medical Systems · 2004 · 2 generations on469descendants
- K974715Advantage 3D XRGE Medical Systems · 1998 · cites it directly298descendants
- K9846343D-AngioSiemens Medical Corp. · 1999 · 2 generations on245descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| +1 | K012313 | CT Colonography/NAVIGATOR2 | Ge Medical Systems, Inc. | 2001 | 1 |
| +1 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| +2 | K041521 | Volume Viewer Plus | General Electric Medical Systems | 2004 | 2 |
| +1 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| +2 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 19 | 0 |
| 2007 | 7 | 0 |
| 2008 | 16 | 0 |
| 2009 | 13 | 0 |
| 2010 | 13 | 0 |
| 2011 | 22 | 0 |
| 2012 | 28 | 0 |
| 2013 | 24 | 0 |
| 2014 | 27 | 0 |
| 2015 | 25 | 0 |
| 2016 | 29 | 0 |
| 2017 | 32 | 0 |
| 2018 | 50 | 0 |
| 2019 | 38 | 0 |
| 2020 | 53 | 0 |
| 2021 | 47 | 0 |
| 2022 | 52 | 0 |
| 2023 | 46 | 0 |
| 2024 | 59 | 0 |
| 2025 | 71 | 1 |
| 2026 | 55 | 0 |
Sources: FDA 510(k) database (decision fields), 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (758)
See all 75810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012313 | CT Colonography/NAVIGATOR2 | 2001 | 580 |
| K972399 | Advantage Windows Volume Rendering Option | 1997 | 516 |
| K974715 | Advantage 3D XR | 1998 | 298 |
| K032483 | Viatronix V3D Explorer, Revision 1.2 | 2003 | 76 |
| K993792 | Smart Vessel Analysis (Smart VA) Option | 1999 | 60 |
| K962010 | Epi-Scope Option for Q Series CT Systems | 1997 | 9 |
| K020658 | Viatronix V3D Colon | 2002 | 4 |
| K040126 | Viatronix V3D Colon, Revision 1.3 | 2004 | 2 |
| K061532 | Gentle Colon (Revision 2.0) | 2006 | 0 |
| K022789 | Viatronix V3D Explorer | 2002 | 0 |
Has anything in its family been recalled? (1 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.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K012313 (Ge Medical Systems, Inc., 2001) has gone furthest, with 580 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
https://510kreport.com/device/K954355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954355: Advantage Windows 3D with Navigator Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954355
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026