Transpara 1.7.2
K221347ScreenPoint Medical B.V. · cleared 2022-08-03 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Transpara® is a software only application designed to be used by physicians to improve interpretation of digital mammography and digital breast tomosynthesis.”
source quote (p.5)
“'Deep learning' algorithms are applied to FFDM images and DBT slices for recognition of suspicious calcifications and soft tissue lesions (including densities, masses, architectural distortions, and asymmetries). Algorithms are trained with a large database of biopsy-proven examples of breast cancer, benign abnormalities, and examples of normal tissue.”
Validation studies (1)
Retrospective clinical
n=10,690 cases
endpoints: Exam based sensitivity for cancer detection; False positive rates; ROC analysis
standards: IEC 62366-1 Edition 1.0 2015-02, ISO 14155 Second edition 2011-02-01, ISO 14971:2019, IEC 62304:2015, IEC 82304-1: 2016
Reported performance (4 observations)
source quote (p.9)
“For 2D, the sensitivity is 95.0% (93.5-96.4) at 0.30 FP/image.”
source quote (p.9)
“The AUC is 0.945 (0.935-0.954) for 2D”
source quote (p.9)
“For DBT, sensitivity is 93.2% (91.0-95.1) at 0.34 FP/volume.”
source quote (p.9)
“and 0.945 (0.936-0.954) for DBT.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K241831 (decision 2024-11-25) from ScreenPoint Medical B.V. for a matching device line ("Transpara (2.1.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241831
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232096 (decision 2023-12-11) from Screenpoint Medical B.V. for a matching device line ("Transpara Density 1.0.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232096
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).