DrAid for Liver Segmentation
K241543VinBrain Joint Stock Company · cleared 2024-12-06 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.6)
“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.”
AlgorithmAI algorithm for semi-automated liver segmentation
source quote (p.5)
“The software utilizes AI algorithms for semi-automated liver segmentation, combined with manual editing capabilities.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (2)
Retrospective clinical
n=450 scans
endpoints: Dice score; HD95
Retrospective clinical
n=450 scans
endpoints: 95% CI upper bound of Volume Error ≤ 5%
Reported performance (1 observation)
diceas written: “Dice score”0.9649CI [0.9631, 0.9667]
source quote (p.9)
“1) Dice score: + Mean 1std: 0.9649 0.0195 + 95% CI Dice: 0. 9649 [0.9631, 0.9667]”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).