Transpara

K193229

ScreenPoint Medical B.V. · cleared 2020-03-05 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.8)
“Transpara™ 1.6.0 is a software-only device.”
AlgorithmDeep learning algorithms
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.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Standalone

sample size not stated

endpoints: detection of soft lesions and calcifications

standards: ISO 14971:2007, IEC 62304:2015, DEN180005

Reader study (MRMC)

n=240 cases

endpoints: superior breast-level area under the receiver operating characteristic curve (AUC, ROC) between conditions when radiologists use Transpara™ to read DBT exams; reading time reduction; non-inferior or higher sensitivity; non-inferior or higher specificity; reading time reduction on normal exams; standalone AUC performance of Transpara™ was non-inferior to the average AUC performance of the readers

standards: ISO 14971:2007, IEC 62304:2015, DEN180005

Reported performance (1 observation)

aurocas written: “auc”0.863
source quote (p.9)
“with the average AUC increasing from 0.833 to 0.863 (P = 0.0025)”

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
4
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

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/K193229