Transpara

K181704

ScreenPoint Medical BV · cleared 2018-11-21 · 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.5)
“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.”
Adaptive (vs locked)No
source quote (p.9)
“Stability tests have been performed to verify that performance of Transpara™ remains stable when processing and pixel spacing varies.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

sample size not stated

endpoints: Sensitivity for calcifications; False positive rate for calcifications; Sensitivity for soft tissue lesions; False positive rate for soft tissue lesions

Reader study (MRMC)

n=240 cases · 2 site(s)

endpoints: area under the receiver operating characteristic curve; sensitivity; specificity; reading time

standards: Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions (Issued on July 3, 2012)

Reported performance (5 observations)

aurocas written: “auc”0.887
source quote (p.11)
“The standalone breast cancer detection performance of Transpara™™ was observed to approach the average performance of the clinical study radiologists when reading mammograms unaided (radiologists' AUC = 0.866 versus Transpara™™ AUC=0.887).”
sensitivityas written: “Sensitivity for calcifications”94.1CI 90.6-97.1
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.”
sensitivityas written: “Sensitivity for soft tissue lesions”72CI 67.4-76.5
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.”
aurocas written: “Average AUC increase for radiologists”0.02CI 0.010 – 0.030
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).”
aurocas written: “P-value for AUC increase”0.0019
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).”

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
6
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

  • 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); 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/K181704