510(k) · Cleared
ClearedAdvantage Windows Tissue Volume 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 Oct 18, 1996 as substantially equivalent to K913770 (General Electric Co., 1991) after a 53-day review. Its family tree reaches back 1 generation to 1991. 1 of the 474 devices in its family, counting itself, has a Class I recall. 472 later devices descend from it.
- Decided
- Oct 18, 1996
- Review
- 53 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913770 (1991). 472 later devices descend from it, 3 citing it directly. 1 of the 474 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- This deviceK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- Descendant · cites it directly · 470 of its ownK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- Descendant · 2 generations on · 379 of its ownK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- Descendant · 3 generations on · 295 of its ownK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- Descendant · 3 generations on · 263 of its ownK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- Descendant · 4 generations on · 222 of its ownK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
Showing 5 of 472 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 472 · See all- K013381Advanced Lung Analysis-1General Electric Co. · 2001 · cites it directly470descendants
- K022013Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002 · 2 generations on379descendants
- K033374Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003 · 3 generations on295descendants
- K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007 · 3 generations on263descendants
- K041484UndecidedSiemens Medical Solutions USA, Inc. · 2004 · 4 generations on222descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| 0 (this device) | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| +1 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| +2 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +3 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| +3 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| +4 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 11 | 0 |
| 2012 | 23 | 0 |
| 2013 | 11 | 0 |
| 2014 | 19 | 0 |
| 2015 | 20 | 0 |
| 2016 | 16 | 0 |
| 2017 | 21 | 0 |
| 2018 | 27 | 0 |
| 2019 | 22 | 0 |
| 2020 | 31 | 0 |
| 2021 | 25 | 0 |
| 2022 | 34 | 0 |
| 2023 | 33 | 0 |
| 2024 | 35 | 0 |
| 2025 | 44 | 1 |
| 2026 | 38 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K913770 | Advantage V.S. CT/MR Rad Diagnostic WorkstationSummary page 1…ulate the volume of any three dimensional structure from a set of CT images. The images are displayed and measured on the CT/MR Advantage Windows Diagnostic Workstation (K913770). The Tissue Volume Option will automate manual measurements and estimates that are currently made regarding the measure of volum… | 1991 |
What descends from it? (472)
See all 4723 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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 | — |
What is it indicated for?
Advantage Windows Tisue Volume Option is intended to calculate the volume of any three dimensional structure from a set of CT images. The images are displayed and measured on the CT/MR Advantage Windows Diagnostic Workstation (K913770). The Tissue Volume Option will automate manual measurements and estimates that are currently made regarding the measure of volume of anatomy and pathology imaged with computed tomography.
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/K963345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963345: Advantage Windows Tissue Volume Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963345
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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