510(k) · Cleared
ClearedAdvantage Windows (AW) Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · LLZ System, Image Processing, Radiological
Cleared on Dec 15, 1998 as substantially equivalent to K941223 (General Electric Co., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 1 of the 479 devices in its family, counting itself, has a Class I recall. 477 later devices descend from it.
- Decided
- Dec 15, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941223 (1994). 477 later devices descend from it, 6 citing it directly. 1 of the 479 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK941223 Advance Analysis SoftwareGeneral Electric Co. · 1994
- This deviceK983256 Advantage Windows (AW) FusionGE Medical Systems · 1998
- Descendant · cites it directly · 442 of its ownK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- Descendant · cites it directly · 204 of its ownK063324 Pet VcarGE Healthcare · 2007 · Recalled
- Descendant · 2 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 164 of its ownK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
Showing 5 of 477 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 477 · See all- K020546Fusion 7DMirada Solutions, Ltd. · 2002 · cites it directly442descendants
- K063324Pet VcarGE Healthcare · 2007 · cites it directly204descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K040305VITREA2 Version 3.5Vital Images, Inc. · 2004 · 2 generations on164descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941223 | Advance Analysis Software | General Electric Co. | 1994 | — |
| 0 (this device) | K983256 | Advantage Windows (AW) Fusion | GE Medical Systems | 1998 | — |
| +1 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| +1 | K063324 | Pet Vcar | GE Healthcare | 2007 | 1 |
| +2 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 17 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 22 | 0 |
| 2013 | 11 | 0 |
| 2014 | 18 | 0 |
| 2015 | 19 | 0 |
| 2016 | 16 | 0 |
| 2017 | 23 | 0 |
| 2018 | 28 | 0 |
| 2019 | 24 | 0 |
| 2020 | 32 | 0 |
| 2021 | 25 | 0 |
| 2022 | 34 | 0 |
| 2023 | 34 | 0 |
| 2024 | 36 | 0 |
| 2025 | 46 | 1 |
| 2026 | 37 | 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 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? (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 |
|---|---|---|---|
| * | K941223 | Advance Analysis SoftwareSummary page 1…t to the device listed below: Model: Fusion and Registration feature of Advance Analysis Software Manufacturer: General Electric Medical Systems, Milwaukee, W1 510(k) #: K941223 Device Description: Advantage Windows Fusion is a software option for the Advantage Windows Workstation that provides easy compa… | 1994 |
What descends from it? (477)
See all 4776 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?
- Its one ancestor has no recall.
- Of its descendants, K020546 (Mirada Solutions, Ltd., 2002) has gone furthest, with 442 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Advantage Windows Fusion provides an easy means for comparison of three dimensional (3D ) images from computed tomography ( CT ) and magnetic resonance ( MR). It allows 3D registration between two volumetric acquisitions, which may come from different acquisition modalities ( CT / MR), for use in diagnostic radiology or radiation therapy planning.
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/K983256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983256: Advantage Windows (AW) Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983256
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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