Medicalgorithmics Unified Arrhythmia Diagnosic System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152550 FDA 510(k)
- FDA Product Code
- DSI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG v2 is an ambulatory electrocardiogram (ECG) monitor designed as a Detector and Alarm for Arrhythmia (product code DSI). It analyzes electrographic signals, classifies detected heartbeats, and identifies rhythm abnormalities to support cardiac diagnostics. The device operates as a portable diagnostic tool for continuous cardiac monitoring outside traditional clinical settings.
This system is supplied as a reusable medical device and is intended for use in clinical and home monitoring environments. It transmits detection results, including annotated heartbeats and full ECG signals, via a cellular network to a remote server for review by healthcare professionals. The device holds FDA 510(k) clearance under Special Controls for Class II devices, with regulatory classification under 870.1025. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the Medicalgorithmics PocketECG v2 used for?
The Medicalgorithmics PocketECG v2 is designed as a portable ambulatory electrocardiogram (ECG) monitor that functions as a Detector and Alarm for Arrhythmia (DSI). It analyzes electrographic signals to classify heartbeats and identify rhythm abnormalities, supporting cardiac diagnostics outside traditional clinical environments. This allows for continuous monitoring in both clinical and home settings, transmitting detection results and full ECG signals wirelessly for review by healthcare professionals.
How is the Medicalgorithmics PocketECG v2 supplied and intended for use?
The Medicalgorithmics PocketECG v2 is supplied as a reusable medical device. It is intended for use in both clinical and home monitoring environments, providing continuous cardiac diagnostics by detecting and classifying arrhythmias. The device transmits its findings via a cellular network to a remote server, enabling healthcare professionals to review the data remotely.
Is the Medicalgorithmics PocketECG v2 single-use or reusable?
The Medicalgorithmics PocketECG v2 is explicitly described as a reusable medical device. This means it is designed for repeated use after appropriate cleaning, maintenance, and reprocessing as per manufacturer guidelines, rather than being intended for single-use applications.
Does the Medicalgorithmics PocketECG v2 require any special handling for sterility?
The provided data does not specify any details regarding sterility requirements for the Medicalgorithmics PocketECG v2. Users should follow the manufacturer’s instructions for cleaning, disinfection, and reprocessing to ensure safe reuse, particularly in clinical settings where multiple patients may be monitored.
How does the Medicalgorithmics PocketECG v2 transmit its diagnostic results?
The Medicalgorithmics PocketECG v2 transmits detection results, including annotated heartbeats and full ECG signals, through a cellular network to a remote server. This wireless capability allows healthcare professionals to access and review the data remotely, facilitating timely cardiac diagnostics and monitoring without the need for in-person visits.
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: Medicalgorithmics Unified Arrhythmia Diagnostic System, MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM by MEDICAL ..., K193104 FDA 510(k) - Unified Arrhythmia Diagnostic System Po...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152550 | Class II | Active |
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Manufacturer
- Manufacturer
- Medicalgorithmics S.A.
Sources (1)
- FDA 510(k) K152550 24 fields · synced Oct 1, 2026