Methodology
How we decide what goes in a profile, how we verify it, and what we will not claim.
Regulatory status
We check every diagnostic product against the FDA 510(k) premarket notification database. For each clearance we record the 510(k) number, device name, decision date, and a plain-English summary of the indications for use, and we link the FDA decision document.
A clearance covers specific indications, such as a detection task, an image type, or a patient age range. When a product markets features beyond those indications, we say so. "FDA cleared" on a vendor's homepage is not enough for us; the decision letter is.
Pricing
We publish prices only when a vendor publishes them or confirms them in writing. Otherwise we describe the pricing model (per location, per provider, per scan) and mark the price as quote-only.
Integrations
Integrations are listed when the vendor documents them publicly. Practice-management and imaging compatibility varies by version, so we recommend confirming your exact stack in writing before signing.
What "tested" means
Where we have used a product, we say how. Where we have not, each profile has a "What we have not verified" section. We do not present vendor-supplied accuracy figures as our own findings.
Freshness
Every profile shows a "last verified" date. Regulatory data is re-checked when new clearances publish; pricing and integrations are re-checked at least quarterly.
Vendor input
Vendors may send corrections with a primary source. We verify before changing anything, and log the change publicly. Vendors cannot pay for inclusion, ranking, or coverage.