510(k) · Cleared
ClearedXelis Dental 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinitt Healthcare Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 14, 2020 as substantially equivalent to K102684 (Infinitt Co., Ltd., 2010) after a 131-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Apr 14, 2020
- Review
- 131 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K942120 (1994). 22 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 6 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 5 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 4 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 3 generations backK052545 Infinitt G3 PacsInfinitt Co., Ltd. · 2005
- 2 generations backK082990 Infinitt XelisInfinitt Co., Ltd. · 2008
- 1 generation backK102684 Xelis DentalInfinitt Co., Ltd. · 2010
- This deviceK193369 Xelis Dental 2.0Infinitt Healthcare Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −6 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −5 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −4 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −3 | K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | 2005 | — |
| −2 | K082990 | Infinitt Xelis | Infinitt Co., Ltd. | 2008 | — |
| −1 | K102684 | Xelis Dental | Infinitt Co., Ltd. | 2010 | — |
| 0 (this device) | K193369 | Xelis Dental 2.0 | Infinitt Healthcare Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 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? (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 |
|---|---|---|---|
| * | K102684 | Xelis DentalSummary page 4…e processing, radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ III. PREDICATE DEVICES Primary Predicate Device: Xelis Dental, K102684, by INFINITT Healthcare Co. Ltd., CFR 892.2050, Product Code LLZ. IV. DEVICE DESCRIPTION Xelis Dental 2.0, is a s… | 2010 |
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 26 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 22 ancestors has a recall.
- 1 other device also cites its predicate K102684.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D…
Read the full statement (123 words)
Xelis Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software.
Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193369: Xelis Dental 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193369
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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