DeepRhythmAI
Basic Information
- Brand Name
- DeepRhythmAI
- Primary DI
- 05903021560742
- Version / Model
- Type: DRAI
- Company Name
- MEDICALGORITHMICS S A
- Labeler DUNS
- 522657576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-06
- Public Version
- 4
- Public Version Date
- 2026-01-08
- Public Version Status
- Update
- Public Device Record Key
- 0d1ee285-4130-4f04-be56-71a72cb7b04b
Device Description
DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. 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 Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
| QYX | Outpatient Cardiac Telemetry | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47699 | Cardiopulmonary physiological parameter analysis software, professional-only | A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05903021560742 | GS1 |