510(k) · Cleared
ClearedINFINITT ULite
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 Mar 24, 2017 as substantially equivalent to K052545 (Infinitt Co., Ltd., 2005) after a 122-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it.
- Decided
- Mar 24, 2017
- Review
- 122 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K942120 (1994). 8 ancestors in all. 6 later devices descend from it, 1 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 deviceK163290 INFINITT ULiteInfinitt Co., Ltd. · 2017
- Descendant · cites it directly · 5 of its ownK211480 NubeXTechheim Co., Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK222781 AugmentoDeeptek Medical Imaging Private Limited · 2023
- Descendant · 3 generations on · 2 of its ownK232891 Carpl (Carpl)Carpl Ai, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK260936 RadioViewAINeurocareai, Inc. (Dba Savelife.Ai) · 2026
- Descendant · 4 generations on · 0 of its ownK253008 maiLinkMaihub Corp. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211480NubeXTechheim Co., Ltd. · 2021 · cites it directly5descendants
- K222781AugmentoDeeptek Medical Imaging Private Limited · 2023 · 2 generations on4descendants
- K232891Carpl (Carpl)Carpl Ai, Inc. · 2024 · 3 generations on2descendants
- K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai) · 2026 · 4 generations on0descendants
- K253008maiLinkMaihub Corp. · 2026 · 4 generations on0descendants
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) | K163290 | INFINITT ULite | Infinitt Co., Ltd. | 2017 | — |
| +1 | K211480 | NubeX | Techheim Co., Ltd. | 2021 | — |
| +2 | K222781 | Augmento | Deeptek Medical Imaging Private Limited | 2023 | — |
| +3 | K232891 | Carpl (Carpl) | Carpl Ai, Inc. | 2024 | — |
| +4 | K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026 | — |
| +4 | K253008 | maiLink | Maihub Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K052545 | Infinitt G3 PacsSummary page 4…Z Predicate Device: 21 CFR 807. 92(a)(3) Device Classification Name system, image processing, radiological 510(k) Number K052545 Device Name INFINITT G3 PACS Applicant INFINITT CO., LTD.… | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211480 | NubeX | 2021 | 5 |
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 23 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K211480 (Techheim Co., Ltd., 2021) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K052545.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
INFINITT ULite, PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for…
Read the full statement (100 words)
INFINITT ULite, PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.
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/K163290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163290: INFINITT ULite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163290
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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