What to send

  1. The product name and FDA submission number shown on the profile.
  2. Your preferred public product URL for the exact tool or product family.
  3. Corrections for modality, anatomy, clinical use, deployment, RIS/PACS integration, and output format.
  4. Pricing category only: per-study, subscription, enterprise license, hardware-bundled, SaaS/cloud, on-prem license, usage-based, or not publicly disclosed.
  5. Public source links for each requested change, such as FDA summary, IFU, labeling, peer-reviewed study, or vendor documentation.
Exact-version rule

Send claims for the FDA-cleared version associated with the listed submission number. Broader platform claims can be included only when clearly labeled as product-family context.