510(k) · Cleared
ClearedVentricular Analysis Toolkit Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 27, 2000 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 451 devices in its family, counting itself, has a Class I recall. 450 later devices descend from it.
- Decided
- Mar 27, 2000
- Review
- 55 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
450 later devices descend from it, 1 citing it directly. 1 of the 451 devices in this family, counting this one, has a Class I recall.
- This deviceK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
- Descendant · cites it directly · 449 of its ownK013422 Cardiq FunctionGE Medical Systems · 2001
- Descendant · 2 generations on · 331 of its ownK041267 Cardiq Analysis IiiGeneral Electric Medical Systems · 2004
- Descendant · 3 generations on · 296 of its ownK052029 Syngo CirculationSiemens AG Medical Solutions · 2005
- Descendant · 4 generations on · 263 of its ownK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- Descendant · 5 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 450 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 450 · See all- K013422Cardiq FunctionGE Medical Systems · 2001 · cites it directly449descendants
- K041267Cardiq Analysis IiiGeneral Electric Medical Systems · 2004 · 2 generations on331descendants
- K052029Syngo CirculationSiemens AG Medical Solutions · 2005 · 3 generations on296descendants
- K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007 · 4 generations on263descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 5 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000315 | Ventricular Analysis Toolkit Option | GE Medical Systems | 2000 | — |
| +1 | K013422 | Cardiq Function | GE Medical Systems | 2001 | — |
| +2 | K041267 | Cardiq Analysis Iii | General Electric Medical Systems | 2004 | — |
| +3 | K052029 | Syngo Circulation | Siemens AG Medical Solutions | 2005 | — |
| +4 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| +5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 15 | 0 |
| 2013 | 12 | 0 |
| 2014 | 14 | 0 |
| 2015 | 22 | 0 |
| 2016 | 17 | 0 |
| 2017 | 21 | 0 |
| 2018 | 25 | 0 |
| 2019 | 21 | 0 |
| 2020 | 30 | 0 |
| 2021 | 23 | 0 |
| 2022 | 38 | 0 |
| 2023 | 34 | 0 |
| 2024 | 39 | 0 |
| 2025 | 45 | 1 |
| 2026 | 37 | 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? (450)
See all 4501 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013422 | Cardiq Function | 2001 | 449 |
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 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K013422 (GE Medical Systems, 2001) has gone furthest, with 449 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/K000315 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000315: Ventricular Analysis Toolkit Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000315
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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