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510(k) Data Aggregation
K Number
K212112Device Name
Cardiologs Holter Platform
Manufacturer
Cardiologs Technologies
Date Cleared
2021-11-18
(135 days)
Product Code
DPS, DOK, DQK
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Cardiologs Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiologs Platform (Also known as Cardiologs ECG Analysis Platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediation. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. The Cardiologs Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis.
The Cardiologs Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.
The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
Cardiologs Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
Device Description
Cardiologs Holter Platform is a software only medical device with the following components made up of:
- An interface which provides tools to measure, analyze, and review numerous ECGs;
- An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.
Cardiologs Holter Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).
Cardiologs Holter Platform works in the following sequence:
- . Upload of digital ECG file to Cardiologs' secured hosting databases (for health data i.e. HIPAA compliant);
- Manual upload: via the web-interface which allows the selection of files to upload on ● the evaluating user's computer
- . Direct upload: with no manual intervention, in the specific cases where the user's hardware is already connected to the Cardiologs' Application Programming Interface (or API): the ECG is automatically sent to Cardiologs' servers.
- II. Processing of the uploaded ECG file;
- III. Analysis of the uploaded ECG performed by Cardiologs' proprietary algorithm, which labels the ECG:
- . Delineation (detection of at least P waves, QRS complexes and T waves on the ECG signal). The output format is a sequence of elements "wave type/start time":
- Abnormality labels: the algorithm provides probability scores on a predefined set of . abnormality labels (multi-label classification);
- IV. Cardiologs Holter Platform displays the resulting analysis, along with the original ECG signal and a variety of tools (ruler, zoom, etc.). Results are made available either on the Cardiologs interface if the user's hardware allows for digital ECG upload, or on an API in cases where the service is available as part of a package with an ECG machine
- V. Cardiologs Holter Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician.
The resulting information is stored on a secured database.
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K Number
K170568Device Name
CardioLogs ECG Analysis Platform
Manufacturer
Cardiologs Technologies
Date Cleared
2017-06-26
(119 days)
Product Code
DPS, DOK
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Cardiologs Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs ECG Analysis Platform can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Cardiologs ECG Analysis Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, ORS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs ECG Analysis Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.
The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
Cardiologs ECG Analysis Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
Device Description
CardioLogs ECG Analysis Platform is made up of:
- An interface which provides tools to measure, analyze and review numerous ECGs;
- An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.
CardioLogs ECG Analysis Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).
CardioLogs ECG Analysis Platform works in the following sequence:
- 1. Upload of digital ECG file to CardioLogs' secured hosting databases (for health data i.e. HIPAA compliant);
- Manual upload: via the web-interface which allows the selection of files to upload on the evaluating user's computer
- Direct upload: with no manual intervention, in the specific cases where the user's hardware is already connected to the CardioLogs' Application Programming Interface (or API): the ECG is automatically sent to CardioLogs' servers.
- 2. Processing of the uploaded ECG file;
- 3. Analysis of the uploaded ECG performed by CardioLogs' proprietary algorithm, which labels the ECG;
- Delineation (detection of at least P waves, QRS complexes and T waves on the ECG signal). The output format is a sequence of elements "wave type/start time/ end time";
- Abnormality labels: the algorithm provides probability scores on a predefined set of abnormality labels (multi-label classification);
- 4. CardioLogs ECG Analysis Platform displays the resulting analysis, along with the original ECG signal and a variety of tools (ruler, zoom, etc.). Results are made available either on the CardioLogs interface if the user's hardware allows for digital ECG upload, or on an API in cases where the service is available as part of a package with an ECG machine;
- 5. CardioLogs ECG Analysis Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician.
The resulting information is stored on a secured database.
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