510(k) · Cleared
ClearedXelis Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinitt Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 8, 2011 as substantially equivalent to K082990 (Infinitt Co., Ltd., 2008) and 1 other predicate after a 91-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Sep 8, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K942120 (1994). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 4 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 3 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 2 generations backK052545 Infinitt G3 PacsInfinitt Co., Ltd. · 2005
- 1 generation backK082990 Infinitt XelisInfinitt Co., Ltd. · 2008
- This deviceK111613 Xelis FusionInfinitt Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −5 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −4 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −3 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −2 | K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | 2005 | — |
| −1 | K082990 | Infinitt Xelis | Infinitt Co., Ltd. | 2008 | — |
| 0 (this device) | K111613 | Xelis Fusion | Infinitt Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 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.
Planning a device in LLZ? 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? (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 |
|---|---|---|---|
| * | K082990 | Infinitt XelisSummary page 1…Classification Name: ) system, image processing, radiological Product code: LLZ Device Classification; 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) (510(k) Number K082990 K070831 Device Classification System, image System, image Name processing, radiological || processing, radiological Voxar 3D Ente… | 2008 |
| * | K070831 | Voxar 3D Enterprise with Colonmetrix and Pet/CT PerfusionSummary page 1…ication Name: ) system, image processing, radiological Product code: LLZ Device Classification; 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) (510(k) Number K082990 K070831 Device Classification System, image System, image Name processing, radiological || processing, radiological Voxar 3D Enterprise w… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 14 ancestors has a recall.
- 3 other devices also cite its predicate K082990.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The Xelis Fusion™ is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists. Images (including mammographic) and data can be stored, communicated, processed and…
Read the full statement (142 words)
The Xelis Fusion™ is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists.
Images (including mammographic) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. In addition, Xelis Fusion™ can be integrated with an institutions HIS or RIS for an integrated an electronic patient record.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.
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/K111613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111613: Xelis Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111613
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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