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Incident · Regulatory action

FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab

Stereotaxis received FDA 510(k) clearance for the Synchrony system, designed to digitize and modernize the interventional cath lab with a 55-inch 4K display consolidating lab system control. Synchrony includes SynX, a cloud-based HIPAA and GDPR-compliant app for remote connectivity and collaboration. The clearance was announced April 6, 2026.

Occurred 2026-04-06 · Genesis RMN / GenesisX at United States · Stereotaxis · United States · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab

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Sources (1)

  1. Stereotaxis IR · https://ir.stereotaxis.com/news-releases/news-release-details/stereotaxis-announces-fda-clearance-and-launch-synchrony-system

Status history

  • Active · 2026-07-22 · agent:recon

Common questions

What happened in FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab?
Stereotaxis received FDA 510(k) clearance for the Synchrony system, designed to digitize and modernize the interventional cath lab with a 55-inch 4K display consolidating lab system control. Synchrony includes SynX, a cloud-based HIPAA and GDPR-compliant app for remote connectivity and collaboration. The clearance was announced April 6, 2026.
When did this incident occur?
The incident is recorded as occurring on April 6, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab?
Genesis RMN / GenesisX by Stereotaxis is the recorded robot involved in this incident at United States.
Has anyone responded to FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-company-ir
Company IR disclosure

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab.

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Canonical ID ab46d800-4da3-4ebc-b839-f5ae6cc0fb77