510(k) · Cleared
ClearedXelis 3D
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 Jul 28, 2011 as substantially equivalent to K082990 (Infinitt Co., Ltd., 2008) and 1 other predicate after a 279-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jul 28, 2011
- Review
- 279 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 deviceK103130 Xelis 3DInfinitt 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) | K103130 | Xelis 3D | 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…ing, radiological Product code: LLZ Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) [510(k) Number' " K082990 K070831 [Device Clastsification 4System, image ~I System, image [Name 3,t~… | 2008 |
| * | K070831 | Voxar 3D Enterprise with Colonmetrix and Pet/CT PerfusionSummary page 1…oduct code: LLZ Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) [510(k) Number' " K082990 K070831 [Device Clastsification 4System, image ~I System, image [Name 3,t~ J processing, radiolog… | 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 2.7 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?
Xelis 3D is a software device intended for viewing of images acquired from various imaging modalities; CT, MR, CR, DR, US, PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mamnmographic images and digitized film screen…
Read the full statement (127 words)
Xelis 3D is a software device intended for viewing of images acquired from various imaging modalities; CT, MR, CR, DR, US, PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mamnmographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mamnmographic images should only be viewed with a monitor approved by FDA for viewing mamnmographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103130: Xelis 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103130
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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