Cardiologs Holter Platform
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212112 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cardiologs Holter Platform is a Holter ECG Monitoring Device designed for continuous ambulatory electrocardiographic recording. It employs deep neural network and cloud-based technology to analyze long-term ECG data, enabling automated detection and assessment of cardiac arrhythmias, including ventricular and atrial rhythms. This platform supports clinical decision-making by providing structured, AI-assisted interpretations of Holter recordings for healthcare professionals.
The device is supplied as a cloud-connected system for use in clinical settings by qualified healthcare providers. It is cleared under FDA 510(k) (K212112) and compliant with MDD/MDR, with no indication of single-use or sterility requirements. The platform does not contain MRI-compatible components, and no specific storage conditions are noted beyond standard medical device handling. Authorizations are tied to its classification as a Diagnostic ECG Device (Product Code: DPS)
Frequently asked questions
What types of cardiac arrhythmias can the Cardiologs Holter Platform detect and analyze?
The Cardiologs Holter Platform is designed to detect and analyze long-term ECG data, specifically focusing on automated identification of ventricular and atrial arrhythmias. Its deep neural network and cloud-based technology assist in structured, AI-assisted interpretations to support clinical decision-making for these conditions.
Is the Cardiologs Holter Platform intended for single-use or can it be reused?
The device data does not specify single-use or sterility requirements, meaning the Cardiologs Holter Platform is not explicitly labeled as single-use. However, standard medical device handling practices should be followed, and reuse would depend on institutional policies and manufacturer guidelines not detailed here.
How is the Cardiologs Holter Platform supplied, and is it cloud-connected?
The Cardiologs Holter Platform is supplied as a cloud-connected system, meaning it relies on cloud-based technology for analyzing and interpreting Holter ECG recordings. This setup enables continuous ambulatory monitoring and AI-assisted analysis for healthcare providers in clinical settings.
Are there any special storage conditions required for the Cardiologs Holter Platform?
The device data does not mention any specific storage conditions beyond standard medical device handling. This means it should be stored under typical environmental conditions for medical equipment, but users should refer to the manufacturer’s instructions for precise guidelines.
What regulatory pathways has the Cardiologs Holter Platform undergone, and what does that mean for its use?
The Cardiologs Holter Platform has undergone FDA 510(k) clearance (K212112) and is compliant with MDD (Medical Device Directive) and MDR (Medical Device Regulation). This indicates it has been evaluated for substantial equivalence to a predicate device and meets EU regulatory standards, ensuring its safety and performance for continuous ambulatory ECG monitoring in clinical settings.
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: Cardiologs AI-assisted ECG analysis - Philips, Cardiologs Holter Platform Review: Pricing, FDA Status & Alternatives ..., PDF Cardiologs Holter for Clinicians, Philips Cardiologs - Experience our Time-Saving AI Solution for ECG ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212112 | Class II | Active |
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Manufacturer
- Manufacturer
- Cardiologs Technologies
Sources (2)
- FDA 510(k) K212112 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026