Philips France Commercial · Class II · Cleared Aug 6, 2025
| K-number | K250569 |
| Device name | Cardiologs Holter Platform |
| Applicant | Philips France Commercial |
| Product code | DPS |
| Device class | Class II |
| Decision date | Aug 6, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.2340 |
The Cardiologs Holter Platform is a software system for analyzing ECG recordings from Holter monitors, event recorders, and ambulatory ECG devices. It provides automated ECG interpretation using artificial intelligence to assist qualified healthcare professionals in assessing arrhythmias in adult and pediatric populations, with results offered as advisory information only.
The device includes an online portal and API interface for ECG upload and analysis. It performs ECG signal processing, QRS and ventricular ectopic beat detection, interval measurement, heart rate measurement, and rhythm analysis. Performance updates enhance accuracy of abnormality detection and expand pediatric indications compared to the predicate device.
Not stated in this summary.
Philips argues substantial equivalence based on minor wording clarifications to indications for use that do not change the device's actual use. Both the predicate and proposed device share similar indications and substantially equivalent technological characteristics and performance specifications. Performance testing demonstrates the proposed device is as safe and effective as the predicate, with differences in accuracy enhancements and expanded pediatric applicability not raising different safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov