Radiology AI Directory

Documented family

MammoScreen reading aid

A partial mapping of MammoScreen 4 and 5 reading-aid records. Density products and other releases are not included in this mapping.

Choose the exact submission below before comparing evidence or opening a checklist. The proposed installed version and licensed modules still need confirmation with the supplier.

All documented families · Evaluation pilot

Documented product family

Related FDA records

These links identify a sourced product-family relationship. They do not transfer evidence, metrics, clearance scope, compatibility, pricing, or availability between submissions.

MammoScreen reading aid

A partial mapping of MammoScreen 4 and 5 reading-aid records. Density products and other releases are not included in this mapping.

Therapixel identifies MammoScreen as its screening-mammography reading software. The manufacturer-prepared K260714 summary explicitly identifies K243679 as MammoScreen 4 and describes both as software versions of MammoScreen. This does not transfer tested input scenarios, evidence, licenses or availability between records.

Family sourceFamily source
  1. Related FDA recordMammoScreen® (4) (K243679)

    MammoScreen 4 reviewed in K243679

    FDA decision: 2025-07-03 · record reviewed 2026-11-05
    FDA source
  2. Related FDA recordMammoScreen® (5) (K260714)

    MammoScreen 5 reviewed in K260714

    FDA decision: 2026-06-26 · record reviewed 2026-11-05
    FDA source
Latest FDA decision among these records
K260714 · 2026-06-26. Latest decision among these mapped records only. This is not a current installed-version or supersession claim.
Latest documented release
The sources do not establish a complete current commercial release chronology.
Current commercial availability
Availability of an exact release and licensed configuration must be confirmed with the supplier.