510(k) · Cleared
ClearedInfinitt Xelis
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 Nov 20, 2008 as substantially equivalent to K041761 (Infinitt Co., Ltd., 2004) and 1 other predicate after a 44-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it.
- Decided
- Nov 20, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K942120 (1994). 12 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 4 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 3 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 2 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 1 generation backK052545 Infinitt G3 PacsInfinitt Co., Ltd. · 2005
- This deviceK082990 Infinitt XelisInfinitt Co., Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK102684 Xelis DentalInfinitt Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK193369 Xelis Dental 2.0Infinitt Healthcare Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK151371 Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom) · 2015
- Descendant · cites it directly · 0 of its ownK111660 Xelis CardiacInfinitt Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK111613 Xelis FusionInfinitt Co., Ltd. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K102684Xelis DentalInfinitt Co., Ltd. · 2010 · cites it directly2descendants
- K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd. · 2020 · 2 generations on0descendants
- K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom) · 2015 · 2 generations on0descendants
- K111660Xelis CardiacInfinitt Co., Ltd. · 2011 · cites it directly0descendants
- K111613Xelis FusionInfinitt Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −4 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −3 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −2 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −1 | K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | 2005 | — |
| 0 (this device) | K082990 | Infinitt Xelis | Infinitt Co., Ltd. | 2008 | — |
| +1 | K102684 | Xelis Dental | Infinitt Co., Ltd. | 2010 | — |
| +2 | K193369 | Xelis Dental 2.0 | Infinitt Healthcare Co., Ltd. | 2020 | — |
| +2 | K151371 | Corporate Dental Imaging (CDI) Application | U.S. Army Dental Command (Dencom) | 2015 | — |
| +1 | K111660 | Xelis Cardiac | Infinitt Co., Ltd. | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K041761 | RapidiacolonSummary page 1…radiological Product code: LLZ Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) K041761 K052545 Device Classification system, ima ge processng system, image Name… | 2004 |
| * | K052545 | Infinitt G3 PacsSummary page 1…code: LLZ Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) K041761 K052545 Device Classification system, ima ge processng system, image Name jrad… | 2005 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K102684 (Infinitt Co., Ltd., 2010) has gone furthest, with 2 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. 2008, 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 TM is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by Radiologists…
Read the full statement (106 words)
XELIS TM is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis.
Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians, and referring Physicians as an adjunctive to standard radiology practices for diagnosis.
Digitized film screen images must not be reviewed for primary image interpretation.
Mammographic images must not be interpreted using this system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082990: Infinitt Xelis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082990
Report an extraction error
Are you the manufacturer?
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