FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab
[REGULATORY ACTION]Apr 6, 2026 · Stereotaxis · Genesis RMN / GenesisX · United States
Failure Mode
REGULATORY ACTION
Event Date
Apr 6, 2026
Primary Entity
Stereotaxis
Robotic Platform
Genesis RMN / GenesisX
Jurisdiction / Location
United States
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://ir.stereotaxis.com/news-releases/news-release-details/stereotaxis-announces-fda-clearance-and-launch-synchrony-system
https://ir.stereotaxis.com/news-releases/news-release-details/stereotaxis-announces-fda-clearance-and-launch-synchrony-system
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Details
Incident Context & FAQ
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.