MammoScreen

K192854

Therapixel · cleared 2020-03-25 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“MammoScreen is a software-only device for aiding interpreting physicians in identifying focal findings suspicious for breast cancer in screening FFDM (full-field digital mammography) acquired with compatible mammography systems.”

Algorithmmedical image processing and machine learning techniques, including 'deep learning' modules, trained on large databases of biopsy-proven examples of breast cancer, benign lesions and normal tissue.

source quote (p.10)

“In MammoScreen, a range of medical image processing and machine learning techniques are implemented. The system includes 'deep learning' modules for recognition of suspicious calcifications and soft tissue lesions. These modules are trained with very large databases of biopsy-proven examples of breast cancer and normal tissue.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=240 images · 1 site(s)

endpoints: AUC under the ROC curve; Sensitivity; Specificity

standards: IEC 62304 Edition 1.1 2015-06 - Medical device software - Software life-cycle processes, IEC 62366-1 Edition 1.0 2015-02 - Medical devices - Application of usability engineering to medical devices

Reported performance (7 observations)

sensitivity0.847CI 0.829, 0.864

source quote (p.13)

“Sensitivity 0.844 (0.815, 0.872) 0.849 (0.827, 0.871) 0.847 (0.829, 0.864)”

specificity0.729CI 0.721, 0.737

source quote (p.13)

“Specificity 0.705 (0.689, 0.722) 0.738 (0.728, 0.747) 0.729 (0.721, 0.737)”

aurocas written: “auc”0.883CI 0.873, 0.892

source quote (p.12)

“ROC AUC 0.868 (0.851, 0.885) 0.887 (0.875, 0.898) 0.883 (0.873, 0.892)”

aurocas written: “LROC AUC (primary, soft tissue lesions, combined)”0.877CI 0.862, 0.890

source quote (p.15)

“LROC AUC (primary) 0.837 (0.811, 0.861) 0.900 (0.884, 0.916) 0.877 (0.862, 0.890)”

sensitivityas written: “FROC Sensitivity @ MS1 (soft tissue lesions, combined)”0.93CI 0.918, 0.940

source quote (p.15)

“FROC Sensitivity @ MS1 0.895 (0.872, 0.915) 0.952 (0.940, 0.963) 0.930 (0.918, 0.940)”

aurocas written: “LROC AUC (primary, calcifications, combined)”0.942CI 0.928, 0.954

source quote (p.16)

“LROC AUC (primary) 0.974 (0.959, 0.985) 0.930 (0.912, 0.948) 0.942 (0.928, 0.954)”

sensitivityas written: “FROC Sensitivity @ MS1 (calcifications, combined)”0.957CI 0.944, 0.969

source quote (p.16)

“FROC Sensitivity @ MS1 0.994 (0.984, 1.000) 0.941 (0.923, 0.956) 0.957 (0.944, 0.969)”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K243685 (decision 2025-08-22) from Therapixel for a matching device line ("MammoScreen BD") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243685
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243679 (decision 2025-07-03) from Therapixel for a matching device line ("MammoScreen® (4)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243679
re_clearance
The FDA AI/ML device list shows a newer 510(k) K241561 (decision 2024-10-02) from Therapixel for a matching device line ("MammoScreen BD") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241561
re_clearance
The FDA AI/ML device list shows a newer 510(k) K240301 (decision 2024-08-01) from Therapixel for a matching device line ("MammoScreen® (3)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240301
re_clearance
The FDA AI/ML device list shows a newer 510(k) K211541 (decision 2021-11-26) from Therapixel for a matching device line ("MammoScreen 2.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K211541

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).