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FDA 510(k)

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

K-Number: K241179 · 2025-07-11

ApplicantVivaQuant, Inc.
Decision Date2025-07-11
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) is a medical device manufactured by VivaQuant, Inc.. It received FDA 510(k) clearance on 2025-07-11 under approval number K241179. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)?

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by VivaQuant, Inc.. The 510(k) number is K241179.

When was Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) approved by the FDA?

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) received FDA 510(k) clearance on 2025-07-11, under approval number K241179.

What company makes Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)?

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) is manufactured by VivaQuant, Inc..

What is the FDA product code for Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)?

The FDA product code for Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) is QYX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

Other Devices by VivaQuant, Inc.

K183704RX-1 Rhythm Express Remote Cardiac Monitoring System K200833RX-1 Rhythm Express Remote Cardiac Monitoring System

Related Devices (Code: QYX)

K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. K162956NOWCARDIO SYSTEMContex International Technologies (Canada), Inc. K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc. K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. K240653SmartCardia 7L Platform (MCT)Smartcardia SA K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.

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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