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 medical-device manufacturer.
Heritage
From the field, into the field.
We are the rare medical-device manufacturer 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.
2005
Synthology founded
Healthcare IT consultancy formed in Pensacola, FL. Initial focus: PACS deployments at standalone hospitals.
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.
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.
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).
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, MDR + Corrections-and-Removals procedures all controlled-document approved in SynthQMS.
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.
In flight
Clinical VNA Tier 2 510(k)
Submission package in preparation for our SaMD Class II clinical archive. Separate from the Non-device software products — purpose-built so the Class II 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.
Regulatory boundaries are code boundaries.
Different classifications (Non-device software, SaMD Class II, 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.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.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.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.
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
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.
FDA Establishment · Official Correspondent
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
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