Thirteen products, two platform tools.

The Synthology portfolio covers the imaging-stack lifecycle end-to-end: DICOM routing, vendor-neutral archiving, structured reporting, migration, whole-slide pathology, encounter workflows, the SynthIQ DICOM load balancer, the SynthCloudConnect result relay, and SynthInSight fleet analytics — thirteen products spanning the §520(o)(1)(D) non-device line, with the VNA Clinical tier on a Tier 2 510(k) path. Plus SynthQMS and SynthVault, the platform tooling that runs underneath.

DICOM routing + archive

Router-pattern hosts

The Router and the five VNA sibling hosts — one binary per regulatory classification. They share architecture, share underlying libraries, and ship as separate executables on different ports so a regulatory class boundary is also a code boundary.

XyDromatics Router

Non-Device · §520(o)(1)(D)

DICOM routing platform.

Ingest from any modality, route by rules, transform tags, anonymize, prefetch, hold-and-release. The flagship workflow orchestrator — both the operating-control plane for an imaging department and the integration hub between modality, EMR, PACS, VNA, and reporting.

Capabilities

  • C-STORE SCP + STOW-RS endpoints
  • Rule-driven routing with per-rule destinations
  • Tag transformation, anonymization, pixel redaction
  • Hold queue + manual release for sensitive studies
  • Q/R prefetch + scheduled forwarding
  • HL7 ingestion + worklist generation

UDI (DI)00810226041004

Default port: 5000

XyDromatics VNA Repository

Non-Device · §520(o)(1)(D)

Long-term DICOM archive.

The DICOM archive host. C-STORE SCP, archive catalog, and DICOMweb endpoints. Pluggable archive store backends: local filesystem, S3-compatible object stores, on-prem NAS. PostgreSQL, SQL Server, or Oracle for the catalog.

Capabilities

  • Pluggable archive store (local / S3 / NAS)
  • Pluggable catalog DB (PostgreSQL / SQL Server / Oracle)
  • DICOMweb (QIDO-RS, WADO-RS) for browser access
  • Lifecycle policies + tiering
  • Per-AE-Title access control
  • Hash-chain-verified write log for regulated retention

UDI (DI)00810226045002

Default port: 5200

XyDromatics VNA Migration

Non-Device · §520(o)(1)(D)

Archive-to-archive migration.

Migrate studies from a legacy PACS/VNA into a target archive — any source, any destination, any DICOM-conformant target. Includes per-study verification, retry on transient failures, scheduling, and progress reporting.

Capabilities

  • Multi-source ingestion (C-STORE SCU/SCP, STOW-RS, file watchers)
  • Per-study verification + checksum
  • Pause/resume + scheduled migration windows
  • Migration progress reporting
  • Tag transformation during migration

UDI (DI)00810226046009

Default port: 5201

XyDromatics VNA Research

RUO · §520(o)(1)(D)

RUO research-only archive.

A Research-Use-Only sibling of the VNA archive line. PHI-anonymized by design, decoupled from clinical workflows, suited for de-identified study sets and longitudinal research projects.

Capabilities

  • PHI anonymization at ingest
  • Cohort-level access control
  • Project-scoped data partitioning
  • Export to research-friendly formats (NIfTI, CSV manifests)
  • NOT for clinical decision-making

Default port: 5202

XyDromatics VNA Clinical

§520(o)(1)(D) today · Tier 2 510(k)

Clinical archive — Tier 2 on a 510(k) path.

Ships today as non-device software under §520(o)(1)(D); its planned Tier 2 version is the diagnostic clinical archive on a Class II 510(k) path. Clinical-tag-edit capability, built-in reporting platform with PowerScribe / Fluency template-import compatibility, and the regulatory boundary that the rest of the product family is deliberately on the other side of.

Capabilities

  • Clinical-tag-edit (license-gated; SaMD-regulated)
  • Built-in reporting platform (template imports from PowerScribe / Fluency)
  • Hospital-grade availability (HA pair, automatic failover)
  • Full audit trail of every clinical-tag change
  • Separate 510(k) submission package (DOC-2026-115)

Default port: 5203

XyDromatics VNA Clinical Research

§520(o)(1)(D) today · Tier 2 510(k)

Dual-posture clinical + research.

A combined Clinical + Research host for institutions that operate both production clinical archives and de-identified research workflows. Ships today as non-device software under §520(o)(1)(D); its planned Tier 2 shares the VNA Clinical Class II 510(k) predicate, with research-mode lanes added.

Capabilities

  • Full clinical-archive feature set
  • PHI-anonymized research lanes
  • Per-lane access control + audit trail
  • Same SaMD predicate as VNA Clinical

UDI (DI)00810226047006

Default port: 5204

Specialized engines

Smaller-footprint products extracted from the Router for specific use cases — structured reporting, migration, whole-slide pathology, encounter workflows. Each is a standalone licensed SKU.

XyDromatics SR Engine

Non-Device · §520(o)(1)(D)

Structured-report ingest + forwarding.

A standalone licensed subset of the Router focused on SR (Structured Report) DICOM objects. Ingests SR from modalities, applies tag transformations, forwards to PACS/VNA + reporting platforms.

Capabilities

  • SR DICOM SOP class support
  • SR-specific tag transformations
  • Forward to PACS/VNA + report distribution
  • Standalone licensable SKU

UDI (DI)00810226043008

Default port: 5101

XyDromatics Migration Engine

Non-Device · §520(o)(1)(D)

Standalone migration appliance.

A standalone migration appliance distinct from VNA Migration. HL7/MWL-driven archive ingest and scheduled sends. Suited for short-lived migration projects where deploying the full VNA Migration product is overkill.

Capabilities

  • HL7/MWL-driven ingest
  • Scheduled sends with retry
  • No persistent archive (transient routing)
  • Standalone licensable SKU

UDI (DI)00810226042001

Default port: 5102

XyDromatics ImageStream Pathology Engine

Non-Device · §520(o)(1)(D)

Whole-slide imaging ingest sidecar.

WSI conversion sidecar for the VNA family. Watches an intake folder, converts native pathology formats (SVS, NDPI, MRXS) to DICOM Supplement 145 WSI, and forwards via STOW-RS to your VNA. The only Windows-only product in the family (OpenSlideNET dependency).

Capabilities

  • Native pathology format conversion (SVS, NDPI, MRXS)
  • DICOM Supplement 145 WSI output
  • STOW-RS forwarding to VNA
  • Watch-folder ingest pattern
  • HIPAA mode (license feature)

UDI (DI)00810226044005

Default port: 5100

XyDromatics Encounter Engine

Non-Device · §520(o)(1)(D)

POCUS-style encounter workflow.

Encounter-driven imaging workflow with mandatory human verification gate. Receives DICOM, matches against an HL7 ADT feed, blocks on human verification, then forwards enriched studies to PACS/VNA. Closes the encounter loop with HL7 ORM^O01 / FHIR ServiceRequest back to the EMR.

Capabilities

  • DICOM ingest + HL7 ADT matching
  • Mandatory human-verification gate
  • Forward to PACS/VNA after verification
  • HL7 ORM^O01 / FHIR ServiceRequest emission
  • POCUS-style encounter UX

UDI (DI)00810226048003

Default port: 5103

SynthIQ

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

Vendor-neutral DICOM load balancer.

Drop-in replacement for F5, NetScaler, or HAProxy in front of any PACS or DICOM Router pool. Routes by Study Instance UID, not TCP 5-tuple — keeps every clinical study together on one backend across associations, follow-up imaging days later, and SynthIQ restarts. Works with any DICOM-conformant backend (Synthology fleet, vendor PACS, research VNAs, cloud-native endpoints).

Capabilities

  • Persistent SUID-keyed study affinity routing
  • Three-tier waterfall: persistent affinity → least-busy → fallback
  • Health-aware backend selection (5s heartbeat polling)
  • Persistent affinity cache (SQLite, PostgreSQL, or SQL Server)
  • Read-only admin SPA + JSON APIs for operators
  • Vendor-neutral by design (heterogeneous pools supported)

UDI (DI)00810226049000

Default port: 11112

SynthCloudConnect

Non-Device · §520(o)(1)(D)

Cross-site DICOM result relay.

Bridges AI-vendor result delivery into firewall-isolated on-prem Router fleets. The AI vendor C-STOREs results to a SynthCloudConnect endpoint; the on-prem Router pulls them down over an existing outbound-initiated mTLS WebSocket. No inbound firewall holes; no Synthology-to-customer initiated traffic.

Capabilities

  • Cross-site DICOM C-STORE bridging (cloud sender → firewall-isolated receiver)
  • Per-tenant result queue with TTL retention + audit
  • Outbound-initiated mTLS WebSocket from on-prem (no inbound firewall changes)
  • Pseudonymization-preserving — round-trips through customer keypair tree
  • Compatible with existing Router AI-vendor routing rules
  • Self-hosted single-tenant deployment (Terraform / MSI / Helm); hosted multi-tenant variant on roadmap

Default port: 5108

SynthInSight

Non-Device · §520(o)(1)(D)

Historical + cross-router fleet analytics.

A standalone analytics surface over the operational history your Synthology products archive. Each product writes a compact, gzipped-NDJSON event archive off its hot database; SynthInSight reads that archive with an embedded columnar (DuckDB) query engine and answers all-time and cross-router questions the live operational dashboards can't — without ever touching the ingest path. Aggregate-only by design: counts, distinct-counts, and daily series — never row-level PHI. Deploys independently of every other product.

Capabilities

  • All-time + cross-router aggregate analytics (count, distinct-count, daily series)
  • Reads the gzipped-NDJSON archive each product's EventArchiver writes — off the hot operational DB
  • Embedded DuckDB columnar query engine (managed-writer / native-reader split)
  • Aggregate-only by design — never returns row-level PHI
  • Bearer-token-gated HTTP API; deploys independently of any other product
  • Windows MSI or Linux tarball

Default port: 5191

Platform tooling

The internal control plane (SynthQMS) and the regulated-document vault (SynthVault) that the regulated products run on. Available to customers as standalone products as well.

SynthQMS

Internal control plane (non-medical-device)

Quality management + CRM control plane.

The internal control plane for the Synthology product family. Document control, training, audits, CAPAs, complaints, MDR, change control. Plus customer / contact / pipeline / estimate / invoice tracking. 21 CFR Part 11-aligned audit trail. ISO 13485 + SOC 2 structured.

Capabilities

  • Controlled-document workflow (draft → review → approve → archive)
  • 21 CFR Part 11 audit trail
  • Training, audits, CAPAs, complaints, MDR
  • CRM (accounts, contacts, leads, pipeline)
  • Estimates, invoices, billing, accounting integration
  • Booth PWA for trade-show lead capture

Default port: 5002

SynthVault

RUO + optional Part 11 mode

Versioned document vault.

Generic file versioning with checkout/checkin, hash-chain audit, integrity sweeps, webhooks, backup/restore. The regulated-document storage backbone of the Synthology product family. Customers can opt into Part-11-friendly retention via a license feature.

Capabilities

  • Checkout / checkin / version history
  • Hash-chain-verified audit log
  • Integrity sweep (re-verify all blobs)
  • Webhooks on every checkin
  • Project + folder organization
  • Optional Part-11 retention mode (license feature)

Default port: 5104

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