About Synthology

Twenty years deploying imaging systems. Now we make them.

Synthology Healthcare Solutions Group spent its first two decades implementing PACS, RIS, CVIS, reporting, and workflow- orchestration systems for hospitals nationwide. In 2025 we formalized what those deployments told us was missing — and released it as the XyDromatics product family. As of April 30, 2026 we are an ISO 13485-aligned non-device software developer.

Heritage

From the field, into the field.

We are the rare non-device software developer whose engineering team has installed competitor systems at hundreds of customer sites. That heritage is the practical advantage of buying from us — we know your existing imaging stack because we probably deployed parts of it.

Synthology spent its first two decades as a Healthcare IT consultancy — implementing PACS, CPACS, RIS, Workflow Orchestration, and Reporting systems for hospitals from standalone facilities to multi-entity national systems. Siemens, Philips, Agfa, GE, Fuji, Merative, Epic, Microsoft (Nuance), Jacobian (M*Modal), Laurel Bridge, DicomSys — we’ve helped deploy them all, learned where each one struggled, and watched the same workflow gaps recur across customer after customer.

The XyDromatics product family is what twenty years of those deployments told us was missing: an imaging stack that respects regulatory boundaries by design (one binary per classification), treats vendor-neutral archiving as the default, follows the DICOM, IHE, HIE, and HL7 standards, and ships with the audit-trail tooling regulated environments actually need rather than retrofitting it later.

The consulting practice didn’t go away. It moved up: our implementation team still deploys imaging stacks for hospitals — including XyDromatics, but also alongside whatever else is already there. We’ve also partnered with IES-Advisors to supplement and enhance our implementation team across workflow-orchestration platforms (Laurel Bridge, DicomSys) and broader vendor-stack expertise.

Timeline

Twenty-plus years, six chapters.

  1. 2005

    Synthology founded

    Healthcare IT consultancy formed in Pensacola, FL. Initial focus: PACS deployments at standalone hospitals.

  2. 2008–2018

    Multi-vendor implementation practice

    Hundreds of imaging-system implementations across Siemens, Philips, Agfa, GE, Carestream, Fujifilm, Merge (now Merative), Epic, Microsoft (Nuance) PowerScribe, Jacobian (M*Modal), Laurel Bridge, DicomSys. Engagements range from single facilities to multi-entity national health systems.

  3. 2019–2024

    Pattern recognition

    After two decades of deploying everyone else's imaging stacks, three patterns surface in every customer: regulatory boundaries handled as afterthoughts, vendor-neutral archiving treated as an upgrade rather than the default, and audit-trail tooling retrofitted instead of designed in.

  4. 2025

    XyDromatics product family announced

    Trademark filed (USPTO Serial 99772465). Product line built around the gaps the consultancy kept seeing: one binary per regulatory classification, vendor-neutral archive as the default, audit-trail tooling shipped from day one. Eight initial products spanning DICOM routing, archiving, structured reporting, migration, pathology, encounter workflows, plus a quality-management control plane (SynthQMS) and a regulated-document vault (SynthVault).

  5. 2026 Q1

    Regulatory infrastructure stood up

    GS1 Company Prefix 81022604 acquired (1,000-GTIN tier). GMDN Member B199739 with codes 60723 + 57967. DUNS 090142131 confirmed. Risk Management Files, Threat Models, CVD Policy, and Corrections-and-Removals procedures all controlled-document approved in SynthQMS.

  6. 2026 Q2

    §520(o)(1)(D) Non-device software determination

    Regulatory re-analysis under FD&C Act §520(o)(1)(D) (added by §3060 of the 21st Century Cures Act of 2016 and implemented by FDA's September 2019 final guidance on medical-device data systems) confirmed that our DICOM/HL7 routing, VNA, workflow, and cloud-transit products are non-device software — not subject to FDA premarket clearance or Device Listing. Customers can purchase and deploy on their timeline.

  7. In flight

    Clinical VNA archive

    A clinical-archive product line maintained as non-device software under FD&C Act §520(o)(1)(D). Built as its own binary — purpose-built so each regulatory boundary is also a code boundary.

What we believe

Four convictions baked into the products.

The XyDromatics family is opinionated. These are the opinions.

01

Regulatory boundaries are code boundaries.

Different classifications (Non-device software under §520(o)(1)(D), RUO) mean different binaries. Not different config flags. Not different tenant databases. Different binaries — so a regulatory audit, a code review, and a compliance question all converge on the same artifact.

02

Vendor-neutral archiving is the default, not the upgrade path.

A medical-data-infrastructure firm that locks customer data in a proprietary format is a contradiction. Every product in the XyDromatics family treats DICOM standards as the wire-format and the storage-format simultaneously.

03

Audit-trail tooling ships day one.

Hash-chain-verified document vault, controlled-document workflow with 21 CFR Part 11 alignment, SBOM per build, threat models per product. None of these are "we'll add them when an auditor asks." They're part of what the products do, every day.

04

Every cross-product boundary respects nominative-fair-use trademarks.

We name competitor systems factually — Siemens, Philips, Microsoft (Nuance), Jacobian (M*Modal), GE HealthCare (Intelerad) — because customers shouldn't have to guess what we mean. We do not imply partnership or endorsement we don't have.

Leadership

Who runs this.

MD

Michael Danson

Founder · CEO · Official Correspondent

Twenty-plus years implementing imaging systems for hospitals — Siemens, Philips, Epic, Agfa, Nuance — across multi-vendor stacks. Designs the XyDromatics product family and serves as Official Correspondent for FDA registration.

Additional team members are listed on the partners page as those pages come online.

Partnerships

The bench behind the bench.

Synthology operates as the ISO 13485-aligned firm + product arm of a broader healthcare-IT delivery network. When an engagement calls for capacity, depth, or specialized vendor relationships beyond what Synthology directly carries, we draw on partner organizations.

IES-Advisors

IES-Advisors

A long-running healthcare-IT advisory practice with deep workflow-orchestration vendor relationships (Laurel Bridge, DicomSys, DataFirst) and a roster of senior implementation consultants Synthology can pull from for larger engagements. The partnership extends Synthology’s implementation capacity and gives customers access to vendor relationships we don’t maintain in-house.

Operations

Where we work from.

Synthology Healthcare Solutions Group, LLC

21 Cliffledge Trl
Black Mountain, North Carolina 28711
United States

ISO 13485-aligned · Non-device software under FD&C Act §520(o)(1)(D)

Official Correspondent: Michael Danson · +1 850 607 3631 · michael.danson@synthologysolutions.com

Want to talk about your imaging stack?

We’ve probably implemented parts of it for someone else. Book a 30-minute conversation.