510(k) · Cleared
ClearedVINT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediimg Corporation · LLZ System, Image Processing, Radiological
Cleared on Oct 15, 2024 as substantially equivalent to K172803 (Infinitt Healthcare Co., Ltd., 2017) and 1 other predicate after a 250-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Oct 15, 2024
- Review
- 250 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K942120 (1994). 17 ancestors in all, the oldest K924605 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 4 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 3 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 2 generations backK052545 Infinitt G3 PacsInfinitt Co., Ltd. · 2005
- 1 generation backK172803 Infinitt PACS 7.0Infinitt Healthcare Co., Ltd. · 2017
- This deviceK240385 VINTMediimg Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −5 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −4 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −3 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −2 | K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | 2005 | — |
| −1 | K172803 | Infinitt PACS 7.0 | Infinitt Healthcare Co., Ltd. | 2017 | — |
| 0 (this device) | K240385 | VINT | Mediimg Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K172803 | Infinitt PACS 7.0Summary page 6…ate Device The identified predicate devices and reference device within this submission are shown as follow: Predicate device A 510(k) Number K172803 Applicant Infinitt Healthcare Co.,Ltd. Regulation Name Medical image management and processing sy… | 2017 |
| * | K222854 | iTFlowSummary page 6…management and processing system Product code LLZ Device Name Infinitt PACS 7.0 Predicate device B 510(k) Number K222854 Applicant Cardio Flow Design Inc. Regulation Name Medical image management and processing system… | 2023 |
| † | K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | 2022 |
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 30 years and passes through 6 companies; a new generation was cleared every 7.0 years on median.
- None of the 17 ancestors has a recall.
- 2 other devices also cite its predicate K172803.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format). It enables: - Importing DICOM-compliant MR Images. - Quantitative analysis of imported images. - Visualization and analysis of blood flow characteristics of cerebral arteries in MR images. - Advanced correction options such as offset correction, background phase correction, and anti-aliasing. - Data…
Read the full statement (114 words)
VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format).
It enables:
- Importing DICOM-compliant MR Images.
- Quantitative analysis of imported images.
- Visualization and analysis of blood flow characteristics of cerebral arteries in MR images.
- Advanced correction options such as offset correction, background phase correction, and anti-aliasing.
- Data visualization as a graph or output as an image or numerical data.
- Providing the right and left carotid and vertebral arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA.
VINT is intended for use with adult (22 years or more) populations who can undergo MRA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240385: VINT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240385
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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