510(k) · Cleared
ClearedmaiLink
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maihub Corp. · LLZ System, Image Processing, Radiological
Cleared on Jan 5, 2026 as substantially equivalent to K232891 (Carpl Ai, Inc., 2024) after a 108-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jan 5, 2026
- Review
- 108 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K942120 (1994). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations between
- 3 generations backK211480 NubeXTechheim Co., Ltd. · 2021
- 2 generations backK222781 AugmentoDeeptek Medical Imaging Private Limited · 2023
- 1 generation backK232891 Carpl (Carpl)Carpl Ai, Inc. · 2024
- This deviceK253008 maiLinkMaihub Corp. · 2026
Show all 9 generations
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 8 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 7 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 6 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 5 generations backK052545 Infinitt G3 PacsInfinitt Co., Ltd. · 2005
- 4 generations backK163290 INFINITT ULiteInfinitt Co., Ltd. · 2017
- 3 generations backK211480 NubeXTechheim Co., Ltd. · 2021
- 2 generations backK222781 AugmentoDeeptek Medical Imaging Private Limited · 2023
- 1 generation backK232891 Carpl (Carpl)Carpl Ai, Inc. · 2024
- This deviceK253008 maiLinkMaihub Corp. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −8 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −7 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −6 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −5 | K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | 2005 | — |
| −4 | K163290 | INFINITT ULite | Infinitt Co., Ltd. | 2017 | — |
| −3 | K211480 | NubeX | Techheim Co., Ltd. | 2021 | — |
| −2 | K222781 | Augmento | Deeptek Medical Imaging Private Limited | 2023 | — |
| −1 | K232891 | Carpl (Carpl) | Carpl Ai, Inc. | 2024 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K232891 | Carpl (Carpl)Summary page 6…21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Primary Predicate device ⚫ 510(k) Number: K232891 ⚫ Applicant: CARPL.AI Inc. ⚫ Trade/Device Name CARPL ⚫ Regulation Number 892.… | 2024 |
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 32 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K232891.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
maiLink, a PACS and radiology workflow management software available as both a desktop/laptop application and a web viewer, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF…
Read the full statement (180 words)
maiLink, a PACS and radiology workflow management software available as both a desktop/laptop application and a web viewer, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, secondary capture tools, imaging gateways. maiLink enables the storage, transmission, processing, and visualization of images and data within the system itself or over computer networks spanning different locations. Only pre-processed DICOM images specifically intended for presentation are suitable for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the maiLink. To ensure accurate interpretation, mammographic images should only be evaluated on a monitor that adheres to the technical specifications outlined by the FDA. This system is designed exclusively for use by proficient and certified medical experts, including physicians, radiologists, and medical technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253008: maiLink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253008
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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