Transpara
K181704ScreenPoint Medical BV · cleared 2018-11-21 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Transpara™ is a software-only device for aiding radiologists with the detection and diagnosis of breast cancer in mammograms.”
source quote (p.6)
“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”
source quote (p.9)
“Stability tests have been performed to verify that performance of Transpara™ remains stable when processing and pixel spacing varies.”
Validation studies (2)
Standalone
sample size not stated
endpoints: Sensitivity for calcifications; Specificity for calcifications; Sensitivity for soft tissue lesions; Specificity for soft tissue lesions
Reader study (MRMC)
n=240 cases · 2 site(s)
endpoints: Area Under the ROC (AUC); Sensitivity; Specificity; Reading time
standards: ISO 14971:2007, IEC 62304:2015
Reported performance (5 observations)
source quote (p.10)
“Results showed that radiologists significantly improved their detection performance when using Transpara™™, with the average AUC increasing from 0.866 to 0.886 (+0.020, 95% CI = 0.010 – 0.030, P=0.0019).”
source quote (p.8)
“Sensitivity for calcifications was 94.1 (90.6-97.1) with a false positive rate of 0.23 (0.22-0.25) marks per image.”
source quote (p.8)
“For soft tissue lesions sensitivity was 72.0 (67.4-76.5) with a false positive rate of 0.033 (0.028-0.037)marks per image.”
source quote (p.11)
“For soft tissue lesions, the AUC increased from 0.886 to 0.902 (mean difference = +0.016, standard error = 0.007)”
source quote (p.11)
“while for calcifications, the AUC was 0.878 in the unaided and 0.898 in the aided mode (mean difference = +0.020, standard error = 0.012).”
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
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K192287 (decision 2019-12-10) 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:K192287
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).