Archive Family

Three archive hosts. One intended use per binary.

The XyDromatics™ Archive Family is three sibling products built on a shared Router-pattern scaffold. Each sibling has a single, deliberate intended use that matches its deployment — and all three are non-device software under FD&C Act §520(o)(1)(D), transferring, storing, converting, and displaying medical device data without clinical interpretation.

The split is intentional. Intended-use scope is a code boundary, not a config flag — different intended uses mean different binaries. A customer deploying Repository for legacy archive doesn’t accidentally pull in Migration’s bulk-drain pipelines, and a Research deployment doesn’t pull in non-research retention features.

Why split the family

Regulatory boundaries are code boundaries.

One intended use per binary

All three siblings perform functions that fall squarely within FD&C Act §520(o)(1)(D) — they transfer, store, convert formats, and display medical device data without clinical interpretation. Per the controlling statute, they are not devices. Each sibling is scoped to a single intended use, so its capability set stays bounded. Different intended use ⇒ different binary. The customer never has to wonder which one they’re running.

Code segregation enforces the boundary

Each sibling ships as its own binary with only its intended-use code compiled in. A licensing mistake or a config-flag slip can’t accidentally enable another sibling’s functionality on the wrong host — the code isn’t in the binary to enable.

Customer deployment matches the regulatory frame

A customer building a legacy-archive consolidation deploys Repository + Migration. A customer running an institutional research program deploys Research (RUO). All three Non-device siblings ship today as non-device software under FD&C Act §520(o)(1)(D).

Audit visibility

Because each binary has one classification, a regulatory audit on any single product is bounded: the SBOM is one binary’s SBOM, the threat model is that product’s threat model, the change-control gate is that product’s gate. No "this feature is in scope of regulation A in this license tier but not in that tier" arguments.

More detail

Where to read further.

  • /regulatory — the firm-level posture page (FD&C Act §520(o)(1)(D), ISO 13485–aligned QMS, CVD program).
  • Individual sibling product pages linked above each carry their own capability matrix, deployment guide, DICOM Conformance Statement reference, and per-binary regulatory framing.
  • For procurement teams: each sibling can be evaluated independently. We do not require the family to be deployed as a bundle.