SmartCardia 7L Platform (MCT)
FDA 510(k) K240653 · Smartcardia SA
510(k) numberK240653
Submission
- Device name
- SmartCardia 7L Platform (MCT)
- Applicant
- Smartcardia SA
Lausanne, CH - Received
- March 7, 2024
- Decision date
- October 31, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYX – Outpatient Cardiac Telemetry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of…
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250793 | RhythmStar System (SL)QYX · Traditional | RhythMedix, LLC | 04/21/2026SE |
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)QYX · Traditional | VivaQuant, Inc. | 07/11/2025SE |
| K240029 | Zio AT® device (A100A1001)QYX · Traditional | iRhythm Technologies, Inc. | 10/21/2024SE |
| K233584 | RhythmStar SystemQYX · Traditional | RhythMedix, LLC | 07/08/2024SE |
| K162956 | Nowcardio SystemQYX · Abbreviated | Contex International Technologies (Canada), Inc. | 09/22/2017SE |
| K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LQYX · Traditional | Lifewatch Services, Inc. | 08/01/2017SE |
| K163512 | Zio AT ECG Monitoring SystemQYX · Traditional | iRhythm Technologies, Inc. | 06/02/2017SE |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX · Abbreviated | Infobionic, Inc. | 03/11/2016SE |
| K133753 | Mome ECG Continuous Detection and Arrhythmia DetectorQYX · Traditional | Infobionic, Inc. | 09/19/2014SE |
| K133701 | Nuvant MCT SystemQYX · Special | Corventis, Inc. | 02/06/2014SE |
More from Corventis, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231276 | SmartCardia 7L PlatformDSI · Traditional | 08/30/2023SE |
Questions and answers
When was SmartCardia 7L Platform (MCT) cleared by the FDA?
SmartCardia 7L Platform (MCT) (K240653) received a 510(k) decision of Substantially Equivalent on October 31, 2024, 238 days after the submission was received.
What is the product code of K240653?
The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.