Identifiers
- 510(k) Number
- K162023 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CardioDay V2.5 is a Holter electrocardiogram (ECG) analysis system designed for continuous 24-hour cardiac monitoring. It provides automated detection, measurement, and analysis of cardiac rhythms, including the QT interval, to support the diagnosis and management of conditions such as Long-QT syndrome. The system processes long-term ECG recordings to enhance sensitivity and specificity in arrhythmia detection, aiding clinicians in assessing cardiac function over extended periods. Its software-driven approach enables detailed review and interpretation of cardiac events captured during ambulatory monitoring.
The CardioDay V2.5 is supplied as a software-based system for use in clinical cardiology settings, requiring connection to a Holter recorder for data acquisition. It is intended for single-use per recording session, with results stored digitally for review by healthcare professionals. The system operates in compliance with FDA 510(k) clearance (K162023) and EU MDR regulations, ensuring adherence to medical device standards. No specific sterility or MRI safety information is provided, and the system is not classified as a reusable medical device. Storage and handling follow standard IT and medical device protocols as outlined in the manufacturer’s instructions.
Frequently asked questions
What types of cardiac conditions can the CardioDay V2.5 help diagnose or monitor, and how does it do this?
The CardioDay V2.5 is specifically designed for continuous 24-hour cardiac monitoring, focusing on automated detection and analysis of cardiac rhythms. It excels at measuring and evaluating the QT interval, which is critical for diagnosing conditions like Long-QT syndrome. By processing long-term ECG recordings, the system enhances the sensitivity and specificity of arrhythmia detection, allowing clinicians to assess cardiac function over extended periods. This software-driven approach enables detailed review and interpretation of cardiac events captured during ambulatory monitoring.
Is the CardioDay V2.5 meant for repeated use over multiple patient sessions, or is it intended for single-use?
The CardioDay V2.5 is intended for single-use per recording session. After capturing and analyzing data for one patient, the system is not designed for reuse. Results are stored digitally for review by healthcare professionals, ensuring each recording session starts fresh with a new instance of the software.
How is the CardioDay V2.5 supplied, and what equipment does a clinic need to use it?
The CardioDay V2.5 is supplied as a software-based system and requires connection to an external Holter recorder for acquiring ECG data. Clinics must already have a Holter recorder to capture the raw cardiac signals, which the CardioDay software then processes for analysis. The system itself does not include physical medical devices beyond the software and its associated IT infrastructure.
What regulatory pathways has the CardioDay V2.5 followed, and what does this mean for its use in clinical settings?
The CardioDay V2.5 has undergone FDA 510(k) clearance (K162023) and complies with EU MDR regulations. This means the device has been evaluated for safety and effectiveness by regulatory authorities in both the U.S. and Europe, ensuring it meets established medical device standards. Clinicians can rely on its compliance with these pathways when integrating it into their cardiac monitoring workflows.
Are there any special storage or handling requirements for the CardioDay V2.5 beyond standard IT and medical device protocols?
The manufacturer specifies that storage and handling of the CardioDay V2.5 should follow standard IT and medical device protocols as outlined in their instructions. Since it is a software-based system, no specific sterility or physical storage conditions (like temperature or humidity) are mentioned beyond typical IT infrastructure requirements. Always refer to the manufacturer’s guidelines for precise operational details.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - Medizin- und Informationstechnik AG, Cardiology - Medizin- und Informationstechnik AG, PDF CardioDay V2 Car - secaso.com.my, PDF CardioDay v2.5 Holter Analysis System - CardiacDirect
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162023 | Class II | Active |
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Manufacturer
- Manufacturer
- Getemed Medizin- Und Informationstechnik Ag
Sources (2)
- FDA 510(k) K162023 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026