Radiology AI Directory

Buyer guides

Mammography AI: workflow and IT checks

Start with how the radiologist will use the output during screening interpretation. Keep the exact product record and installed system build attached to every workflow question.

Agent source review by codex-source-review: . These are editorial evaluation questions, not clinical, procurement or local compatibility approval.

1. Match the reading role and inputs

MammoScreen 5 K260714 describes a concurrent reading and reporting aid for screening mammograms using compatible full-field digital mammography and tomosynthesis systems, with compatible priors where available. Its analysis alone must not determine patient management. This is one exact-record example, not a description of every mammography AI tool.

  • Is the proposed use concurrent interpretation, another reading role, or a worklist change? Match each requested role to current labeling.
  • Which acquisition systems, images and prior examinations are supported by the proposed software version? Identify unsupported inputs explicitly.
  • What will readers see when priors are absent or input requirements are not met?

Source context: FDA K260714: MammoScreen 5

2. Test the complete display path

Review both ends of the intended interface. DICOM documentation can guide the integration discussion, but broad conformance does not prove the requested display behavior on Merge, Visage, Sectra, AGFA or IntelePACS at a particular site.

  • Which exact PACS or viewer release, AI version, output objects, licenses and hanging protocols will be tested together?
  • Can readers identify the AI result's patient, examination and software version and return to the underlying images without ambiguity?
  • How will delayed results, corrected studies, prior matching, downtime and rollback appear to the reader? Assign an owner to each test.

Source context: DICOM PS3.2: Scope and Field of Application

3. Keep scope, evidence and the offer separate

The Transpara 2.1.0 K241831 record provides another exact submission to inspect alongside MammoScreen. A comparison is an evidence collection task; it does not establish equal inputs, equivalent results or a preferred supplier. Written offer scope and local acceptance remain separate checks.

  • Do the studies describe the same reading role, examination type, population and endpoint that your team plans to evaluate?
  • Who will review discordant results and assess workflow effects before deciding whether the proposed use is acceptable?
  • Does the quote identify all required interfaces, workstations, modules, support and upgrade obligations? Take unresolved items to the committee packet.

Source context: FDA K241831: Transpara 2.1.0 · FDA list of artificial intelligence enabled medical devices

Take the next step

Inspect the exact example records

Examples illustrate the questions above. They are not a ranking, equivalent alternatives, confirmed offers or the complete market.

Documented family navigation: MammoScreen reading aid. Confirm each record's own scope.

Explore a private interpretation-capacity and cost scenario · Read a fictional committee packet · Check system compatibility scope

The worksheets and scenario use your assumptions. Save or attach private inputs explicitly; public evidence does not turn those inputs into verified results. The public sample uses fictional facility values.

Sources and scope

Sources anchor the stated regulatory or interoperability context. The questions are original editorial prompts; a citation does not validate a financial assumption or establish local fit. Source dates below apply to this guide, not the whole directory.

  1. FDA K260714: MammoScreen 5

    PDF pages 7-8: indications and predicate comparison. Checked .

    Exact K260714 reading role and compatible-input context; no installed pairing is established.

  2. FDA K241831: Transpara 2.1.0

    Decision letter: device name and submission identity. Checked .

    Exact-record identity for an example comparison; no comparative performance claim.

  3. DICOM PS3.2: Scope and Field of Application

    Chapter 1; page identifies edition 2026d at review. Checked .

    Conformance statement context; no viewer-specific compatibility conclusion.

  4. FDA list of artificial intelligence enabled medical devices

    About this list and public decision summaries. Checked .

    Regulatory record context only, not purchasing or local validation evidence.

Dataset and maintenance dates · Methods · Submit a source-backed correction