Transpara

K192287

Screenpoint Medical B.V. · cleared 2019-12-10 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Transpara™ is a software-only device for aiding radiologists with the detection and diagnosis of breast cancer in mammograms.”

AlgorithmThe software applies algorithms for recognition of suspicious calcifications and soft tissue lesions, which are trained with large databases of biopsy proven examples of breast cancer, benign lesions and normal tissue. The image analysis unit includes machine learning components trained to detect calcifications and soft tissue lesions.

source quote (p.6)

“The software applies algorithms for recognition of suspicious calcifications and soft tissue lesions, which are trained with large databases of biopsy proven examples of breast cancer, benign lesions and normal tissue. The image analysis unit includes machine learning components trained to detect calcifications and soft tissue lesions and a component to pre-process images in such a way that images from different vendors can be processed by the same algorithms.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (2)

Standalone

sample size not stated

endpoints: algorithm performance has improved in comparison to Transpara 1.3.0; similar performance is achieved for Fujifilm

Reader study (MRMC)

sample size not stated

endpoints: evidence for safety and effectiveness

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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) 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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K221347 (decision 2022-08-03) from ScreenPoint Medical B.V. for a matching device line ("Transpara 1.7.2") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221347
re_clearance
The FDA AI/ML device list shows a newer 510(k) K210404 (decision 2021-06-02) from ScreenPoint Medical B.V. for a matching device line ("Transpara 1.7.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K210404
re_clearance
The FDA AI/ML device list shows a newer 510(k) K193229 (decision 2020-03-05) from ScreenPoint Medical B.V. for a matching device line ("Transpara") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K193229

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).