DrAid for Radiology v1
K221241VinBrain Joint Stock Company · cleared 2022-09-01 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“The DrAid™ for Radiology v1 is a radiological computer-assisted triage & notification software product designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pneumothorax in medical care environment. DrAid™ analyzes cases using an artificial intelligence algorithm to features suggestive of suspected findings. It makes case-level output available to a PACS for worklist prioritization or triage.”
Algorithmartificial intelligence algorithm
source quote (p.4)
“DrAid™ analyzes cases using an artificial intelligence algorithm to features suggestive of suspected findings.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.4)
“Following receipt of chest radiographs, the software device de-identifies a copy of each chest radiographs in DICOM format (.dem) and automatically analyzes each image to identify features suggestive of pneumothorax.”
Validation studies (2)
Retrospective clinical
n=565 images
endpoints: AUC; Sensitivity; Specificity
Retrospective clinical
n=285 images · 4 site(s)
endpoints: AUC; Sensitivity; Specificity
Reported performance (3 observations)
sensitivity0.9461CI [0.9216, 0.9676]
source quote (p.10)
“Sensitivity 0.9461 0.0117 0.9676 0.9216”
specificity0.9758CI [0.9636, 0.9865]
source quote (p.10)
“Specificity 0.9758 0.0056 0.9865 0.9636”
aurocas written: “auc”0.961CI [0.9473, 0.9730]
source quote (p.10)
“AUC 0.9610 0.0065 0.9730 0.9473”
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
0
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).