Transpara 1.7.2

K221347

ScreenPoint Medical B.V. · cleared 2022-08-03 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
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).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

n=10,690 images · 8 site(s)

endpoints: cancer detection performance

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 (3 observations)

sensitivity0.95CI 93.5-96.4
source quote (p.9)
“For 2D, the sensitivity is 95.0% (93.5-96.4) at 0.30 FP/image.”
aurocas written: “auc”0.945CI 0.935-0.954
source quote (p.9)
“The AUC is 0.945 (0.935-0.954) for 2D and 0.945 (0.936-0.954) for DBT.”
sensitivityas written: “DBT Sensitivity”0.932CI 91.0-95.1
source quote (p.9)
“For DBT, sensitivity is 93.2% (91.0-95.1) at 0.34 FP/volume.”

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
2
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

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/K221347