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FDA 510(k)

Synchrony

K-Number: K253473 · 2026-04-01

ApplicantStereotaxis, Inc.
Decision Date2026-04-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Synchrony is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2026-04-01 under 510(k) 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. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K253473.

When did Synchrony receive FDA 510(k) clearance?

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

Who is the listed applicant for Synchrony?

The FDA 510(k) record lists Stereotaxis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synchrony?

The FDA product code for Synchrony is DQK.

Other records listing Stereotaxis, Inc. as applicant

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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.

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