MammoScreen® (5)

K260714

Therapixel · cleared 2026-06-26 · product code QDQ · Radiology

FDA 510(k) summary for MammoScreen® (5) (K260714)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
1
Product code
QDQ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“MammoScreen® 5 is a concurrent reading medical software device using artificial intelligence to assist radiologists in the interpretation of mammograms.”
Algorithmartificial intelligence/machine learning-based software algorithm with deep learning modules
source quote (p.9)
“MammoScreen 5 is powered by artificial intelligence/machine learning-based software algorithm”
Adaptive (vs locked)No
source quote (p.12)
“The algorithm behind MammoScreen 5 did not change/evolve compared to its predecessor, accordingly a standalone performance testing was deemed sufficient to validate and claim compatibility with the newly introduced scenarios.”
PCCPNo
source quote (p.11)
“No new PCCP included”
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Standalone

n=9,789 patients

endpoints: AUCROC; AUCLROC; Non-inferiority in standalone cancer detection performance

standards: IEC 62304:2006/A1:2016, IEC 62366-1:2015+AMD1:2020

Reported performance (1 observation)

aurocas written: “auc”0.911CI 0.894, 0.928
source quote (p.13)
“AUCROC 0.911 (0.894, 0.928) Mammogram level”

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

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

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.

Related FDA clearances

More AI/ML devices under product code QDQ

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K260714