510(k) · Cleared
ClearedRapidiacolon
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 13, 2004 as substantially equivalent to K992654 (Voxar Limited, 1999) after a 13-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it.
- Decided
- Jul 13, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954678 (1996). 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 2 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 1 generation backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- This deviceK041761 RapidiacolonInfinitt Co., Ltd. · 2004
- Descendant · cites it directly · 6 of its ownK082990 Infinitt XelisInfinitt Co., Ltd. · 2008
- Descendant · 2 generations on · 2 of its ownK102684 Xelis DentalInfinitt Co., Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK193369 Xelis Dental 2.0Infinitt Healthcare Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK151371 Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom) · 2015
- Descendant · 2 generations on · 0 of its ownK111660 Xelis CardiacInfinitt Co., Ltd. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082990Infinitt XelisInfinitt Co., Ltd. · 2008 · cites it directly6descendants
- K102684Xelis DentalInfinitt Co., Ltd. · 2010 · 2 generations on2descendants
- K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd. · 2020 · 3 generations on0descendants
- K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom) · 2015 · 3 generations on0descendants
- K111660Xelis CardiacInfinitt Co., Ltd. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −2 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −1 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| 0 (this device) | K041761 | Rapidiacolon | Infinitt Co., Ltd. | 2004 | — |
| +1 | K082990 | Infinitt Xelis | Infinitt Co., Ltd. | 2008 | — |
| +2 | K102684 | Xelis Dental | Infinitt Co., Ltd. | 2010 | — |
| +3 | K193369 | Xelis Dental 2.0 | Infinitt Healthcare Co., Ltd. | 2020 | — |
| +3 | K151371 | Corporate Dental Imaging (CDI) Application | U.S. Army Dental Command (Dencom) | 2015 | — |
| +2 | K111660 | Xelis Cardiac | Infinitt Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…ace Edinburgh, UK EH6 5 NP Device Name: plug 'n view 3d, version 1 0 510(k) Number: K992654 Decision Date: 11/05/1999 Decision: Substantially Equivalent Panel Code… | 1999 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082990 | Infinitt Xelis | 2008 | 6 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082990 (Infinitt Co., Ltd., 2008) has gone furthest, with 6 descendants of its own.
- 15 other devices also cite its predicate K992654.
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?
RapidiaColon TM is a software application for the display and 3D visualization of medical data derived from CT and MRI scanners. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041761: Rapidiacolon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041761
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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