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

Healthcare imaging infrastructure — built, deployed, managed.

From DICOM routing and vendor-neutral archiving to whole-slide pathology, structured reporting, and migration tooling — Synthology builds the imaging software that runs modern healthcare departments. We’ve spent twenty years deploying these systems for hospitals. Now we make them.

Products
13

across the imaging lifecycle

FDA
Registered

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

Vendor experience
20+

Siemens, Epic, Philips, Agfa & more

Implementation experience at

  • Mayo Clinic
  • Cleveland Clinic
  • Northwell Health
  • OU Health
  • El Camino Hospital
  • Denver Health
  • …and many more

Our team has worked on-site as technical resources, leading imaging-system implementations across vendor stacks at health systems nationwide.

Implementation, Interoperability & Migration experience with

  • Epic
  • Siemens Healthineers
  • Agfa HealthCare
  • Philips
  • Microsoft (Nuance)
  • Jacobian (M*Modal)
  • Merative (Merge)

Two decades of deployment, migration, and integration work across the major imaging-vendor stacks — applied to your modernization or to our own products.

Product family

The imaging stack, end to end.

Thirteen products covering DICOM routing, vendor-neutral archiving, structured reporting, migration, whole-slide pathology, encounter workflows, load balancing, cross-site result relay, and fleet analytics. Plus the platform tooling that runs underneath: quality management and the document vault that keeps everything regulator-ready.

XyDromatics Router

DICOM routing platform — ingest from any modality, route by rules, transform tags, anonymize, prefetch, hold-and-release.

Non-Device · §520(o)(1)(D)
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XyDromatics VNA Family

Five Router-pattern VNA hosts: Repository, Migration, Research (RUO), Clinical, Clinical+Research. Non-device software under FD&C Act §520(o)(1)(D).

Non-Device · §520(o)(1)(D)
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XyDromatics SR Engine

Structured-report ingest, transformation, and forwarding. Standalone licensed subset extracted from Router.

Non-Device · §520(o)(1)(D)
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XyDromatics Migration Engine

HL7/MWL-driven archive ingest and scheduled sends. The standalone migration appliance for legacy-system retirements.

Non-Device · §520(o)(1)(D)
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XyDromatics Pathology Engine

Whole-slide imaging ingest. Converts native pathology formats (SVS, NDPI, MRXS) to DICOM Supplement 145 WSI and forwards to your VNA.

Non-Device · §520(o)(1)(D)
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XyDromatics Encounter Engine

POCUS-style encounter workflow with mandatory human-verification gate. Receives DICOM, matches HL7 ADT, blocks on verification, forwards enriched studies.

Non-Device · §520(o)(1)(D)
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SynthIQ

Vendor-neutral DICOM load balancer. Drop-in replacement for F5, NetScaler, or HAProxy in front of any PACS or Router pool — keeps clinical studies together on one backend by routing on Study Instance UID, not TCP 5-tuple.

Non-Device · §520(o)(1)(D) Patent Pending
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SynthCloudConnect

Cross-site DICOM result relay. Bridges AI-vendor result delivery into firewall-isolated on-prem Router fleets via outbound-initiated mTLS WebSocket — no inbound firewall holes, no Synthology-to-customer initiated traffic. Generally available.

Non-Device · §520(o)(1)(D)
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SynthInSight

Standalone historical + cross-router analytics. Reads the gzipped-NDJSON event archive each product writes and answers all-time, fleet-wide aggregate questions with an embedded DuckDB engine — off the hot path, aggregate-only (never row-level PHI). Pre-launch.

Non-Device · §520(o)(1)(D)
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Services

We make the products. We deploy them. We run them for you.

Three tiers, from one-time deployment through ongoing operation. Implementation services aren’t XyDromatics-only — twenty years of deploying competitor imaging stacks means we can move you off any legacy system, onto our products or alongside them.

Tier 1

Implementation

Deploy any imaging system — including ours.

  • XyDromatics product deployment (any host, any topology)
  • Migration off legacy PACS/VNA/RIS — Siemens, Philips, Merative (Merge), Optum (Change), Fujifilm, GE Healthcare
  • EMR/EHR integration — Epic, Cerner
  • Reporting — Microsoft (Nuance), Jacobian (M*Modal)
  • CVIS — Siemens, Agfa, GE, Merative (Merge), Baxter (Epiphany)
  • Third-party imaging applications — Philips, Materialise, Siemens, Hyland, Microsoft, GE HealthCare (Intelerad), plus AI vendors (Aidoc, Riverain) and more
  • Workflow Orchestration — Laurel Bridge, DicomSys
  • Go-live support, user training, workflow analysis

Who it’s for

Hospitals + imaging centers replacing or modernizing imaging infrastructure.

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Tier 2

Professional

Strategy, workflow, and training — vendor-agnostic.

  • Imaging-department workflow optimization
  • Vendor selection + RFP support
  • Best-practice review against 21 CFR Part 11 / ISO 13485 / IHE profiles
  • Custom user-training programs
  • Staff augmentation for project teams
  • Lessons-learned reviews and post-mortems

Who it’s for

Health systems planning a multi-year imaging modernization or compliance posture upgrade.

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Tier 3

Managed

We run the stack so your team doesn’t have to.

  • 24×7 operation of XyDromatics-deployed environments
  • Patch + upgrade management
  • License renewal + DICOM port reconciliation
  • Capacity planning + storage tiering
  • Audit-trail attestation for SOC 2 / Part 11 reviews
  • Defined SLAs with named technical contacts

Who it’s for

Customers running XyDromatics in production who want a service-level commitment instead of in-house operations overhead.

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Regulatory posture

Software you can deploy today.

Our DICOM/HL7 routing, VNA, and workflow products are non-device software under FD&C Act §520(o)(1)(D) — the statutory carve-out from the 21st Century Cures Act of 2016. Customers can purchase and deploy without waiting on FDA premarket clearance. We maintain ISO 13485–aligned quality discipline anyway, because shipping reliable medical-data infrastructure demands it.

FD&C Act §520(o)(1)(D)

Active
Non-Device Software

21st Century Cures Act §3060 (2016) statutory carve-out: software solely transferring, storing, converting formats, or displaying medical device data is not a device. Our products fall within.

QMS Framework

Active
ISO 13485-aligned

Design controls, document control, CAPA, complaint handling, software life-cycle to IEC 62304 — operated internally because good engineering demands it, not because a regulator requires it.

FDA Guidance (2019)

Active
Non-device under §520(o)(1)(D)

FDA Sep 2019 final guidance "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" — implements §520(o)(1)(D) and defines the non-device carve-out our products fall within.

FD&C Act §520(o)(1)(D)

Active
Non-Device · §520(o)(1)(D)

XyDromatics VNA Clinical, like every Synthology product as shipped, is non-device software under FD&C Act §520(o)(1)(D). It is not a current or pending FDA-regulated device and requires no premarket clearance to purchase or deploy.

Coordinated Vuln. Disclosure

Active
RFC 9116

Public security.txt + PGP-encrypted submission path + 5-business-day acknowledgment SLA. Threat models, SBOM, penetration test reports per product.

DUNS

Active
090142131

Active. Auto-maintained business identifier.

Heritage

Twenty years deploying imaging systems. Now we make them.

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. That’s the practical advantage of buying from a manufacturer that came up through the field. We know the stack you’re already running, because we probably installed part of it. We’ve also partnered with IES-Advisors to supplement and enhance our implementation team.

Ready to modernize your imaging stack?

Book a 30-minute conversation with our team. We’ll review your current architecture, identify migration paths, and walk through the XyDromatics product family in detail.