# K232161: DeepRhythm Platform

- Pathway: 510(k) (Traditional)
- Applicant: Medicalgorithmics S.A.
- Decided: Jun 20, 2024 after 336 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003621 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212112: Cardiologs Holter Platform, Cardiologs Technologies (2021) Summary page 4.

## Indications for use
The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in adult patients. The product supports downloading and analyzing data recorded in compatible formats from I-channel and 2-channel ambulatory ECG recording devices used for the arrhythmia diagnostics such as Holter, event recorder or other similar devices when retrospective assessment of the rhythm is necessary. The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arrhythmias. The DeepRhythm Platform utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events. The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAl. The DeepRhythm 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.

Source page: https://510kreport.com/device/K232161
Methodology: https://510kreport.com/methodology