VinDr-Mammo

K233108

VinBigData Joint Stock Company · cleared 2024-05-23 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Operating as non-invasive computer-assisted software, known as SaMD, it employs a machine learning algorithm to identify potential suspicious findings within the images.”
Algorithmartificial intelligence algorithm / machine learning algorithm
source quote (p.3)
“VinDr-Mammo utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam-level. Operating as non-invasive computer-assisted software, known as SaMD, it employs a machine learning algorithm to identify potential suspicious findings within the images.”
Adaptive (vs locked)No
source quote (p.5)
“During the algorithm's training, independent datasets from various global sites were utilized, ensuring a robust and diverse training experience.”
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=1,000 patients

endpoints: Sensitivity; Specificity; AUC

Retrospective clinical

n=1,864 patients · 1 site(s)

endpoints: Sensitivity; Specificity; AUC

Reported performance (3 observations)

sensitivity0.9CI 0.877-0.921
source quote (p.15)
“Sensitivity 0.900 0.877 0.921”
specificity0.91CI 0.897-0.922
source quote (p.15)
“Specificity 0.910 0.897 0.922”
aurocas written: “auc”0.962CI 0.957-0.971
source quote (p.16)
“AUC 0.962 0.957 0.971”

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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K233108