FDA 510(k)

Synchrony

K-Number: K253473 · 2026-04-01

Decision Date2026-04-01

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Synchrony is a medical device manufactured by Stereotaxis, Inc.. It received FDA 510(k) clearance on 2026-04-01 under approval number K253473. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synchrony?

Synchrony is a medical device that received FDA 510(k) clearance on 2026-04-01. It is manufactured by Stereotaxis, Inc.. The 510(k) number is K253473.

When was Synchrony approved by the FDA?

Synchrony received FDA 510(k) clearance on 2026-04-01, under approval number K253473.

What company makes Synchrony?

Synchrony is manufactured by Stereotaxis, Inc..

What is the FDA product code for Synchrony?

The FDA product code for Synchrony is DQK.

Other Devices by Stereotaxis, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.