510(k) · Cleared
ClearedDrAid™ for Liver Segmentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vinbrain Joint Stock Company · QIH Automated Radiological Image Processing Software
Cleared on Dec 6, 2024 as substantially equivalent to K131498 (Edda Technology, Inc., 2013) after a 189-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Dec 6, 2024
- Review
- 189 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954678 (1996). 16 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 4 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 3 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 2 generations backK082228 Planisight LinasysPathfinder Therapeutics, Inc. · 2008
- 1 generation backK131498 Iqqa-Liver Multimodality SoftwareEdda Technology, Inc. · 2013
- This deviceK241543 DrAid™ for Liver SegmentationVinbrain Joint Stock Company · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −4 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −3 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −2 | K082228 | Planisight Linasys | Pathfinder Therapeutics, Inc. | 2008 | — |
| −1 | K131498 | Iqqa-Liver Multimodality Software | Edda Technology, Inc. | 2013 | — |
| 0 (this device) | K241543 | DrAid™ for Liver Segmentation | Vinbrain Joint Stock Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K131498 | Iqqa-Liver Multimodality SoftwareSummary page 5…n: Class II Classification Name: System, Image Processing, Radiological Identification of Predicate Device: 510(k) Number: K131498 Device Name: IQQA-LIVER MULTIMODALITY SOFTWARE Manufacturer: EDDA TECHNOLOGY, INC. 1. Device Description Summary Device Ident… | 2013 |
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 28 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K131498.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
DrAid™ for Liver Segmentation is a web-based software, non-invasive image analysis application designed for the visualization, evaluation, and reporting of liver and physician identified lesions using multiphase images (with slice thickness <= 3.0mm) of patients aged and older than 22 years old obtained from CT scanners. The software provides a range of tools for image viewing, processing, and reporting. The software enables professionals, including…
Read the full statement (250 words)
DrAid™ for Liver Segmentation is a web-based software, non-invasive image analysis application designed for the visualization, evaluation, and reporting of liver and physician identified lesions using multiphase images (with slice thickness <= 3.0mm) of patients aged and older than 22 years old obtained from CT scanners. The software provides a range of tools for image viewing, processing, and reporting.
The software enables professionals, including physicians and technicians, to review and analyze multiphase volume datasets of the liver. DrAid™ for Liver Segmentation operates in a semiautomated quantitative imaging function, utilizing an Al algorithm to generate liver segmentation that is then editable by the physician if necessary. Additionally, the device provides tools for manual segmentation within user input of seed points and boundary editing for physician-identified lesions within the liver. Professionals can assess liver volume (mm³), liver lesion volume (mm³), and maximum lesion diameter (mm), position, thereby aiding in evaluation and treatment planning.
It is important to note that the software is intended for use by trained professionals, including physicians and technicians. The image source for analysis is DICOM, allowing compatibility with standard medical imaging data formats.
Note: DrAid™ for Liver Segmentation does not generate diagnoses or potential findings directly.
The interpretation of the image data and the clinical decision-making process should be performed by qualified healthcare professionals. The installation and deployment of the software medical device should be carried out by VinBrain and trained technicians.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241543: DrAid™ for Liver Segmentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241543
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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