# K241543: DrAid™ for Liver Segmentation

- Pathway: 510(k) (Traditional)
- Applicant: Vinbrain Joint Stock Company
- Decided: Dec 6, 2024 after 189 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954678 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131498: Iqqa-Liver Multimodality Software, Edda Technology, Inc. (2013) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K241543
Methodology: https://510kreport.com/methodology