DeepRhythmAI
Medicalgorithmics S.A.
MEDICALGORITHMICS S.A.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007770164 | 3007770164 | MEDICALGORITHMICS S.A. | 1 | N | 2026-01-01 | AL. JEROZOLIMSKIE 81 WARSAW Mazowieckie PL 02-001 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 105190 | 1369660057 | K253141 | DeepRhythmAI | DQK | 2025-12-11 |
| 105190 | 1603992246 | K250932 | DeepRhythmAI | DQK | 2025-05-27 |
| 105190 | 1212965148 | K232161 | DeepRhythm Platform | DPS | 2024-06-20 |
| 105190 | 1265972314 | K210758 | Q Patch | MWJ | 2022-06-02 |
| 105190 | 1691922826 | K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | DSI | 2020-04-09 |
| 105190 | 1556763853 | K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | DSI | 2018-07-11 |
| 105190 | 1030807962 | K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | DSI | 2015-10-08 |
| 105190 | 1797604269 | K124060 | MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | DSI | 2013-02-21 |
Product Codes Associated With Registrations#
PMN#
DeepRhythmAI
Medicalgorithmics S.A.
DeepRhythm Platform
Medicalgorithmics S.A.
DeepRhythmAI
Medicalgorithmics S.A.
Q Patch
Medicalgorithmics S.A.
Unified Arrhythmia Diagnostic System PocketECG IV
Medicalgorithmics S.A.
Medicalgorithmics Unified Cardiac Rehabilitation System
Medicalgorithmics S.A.
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
MEDICALGORITHMICS S.A.
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
MEDICALGORITHMICS S.A.
GUDID#
DeepRhythmAI - 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.
2026-03-25
DeepRhythmAI - 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.
2025-06-06
PocketECG IV - Unified Arrhythmia Diagnostic System - The holster type P3HL-AB-UNI is an accessory to the PocketECG IV - Medicalgorithmics Unified Arrhythmia Diagnostic System. It is a belt holder for PocketECG transmitters (types P4TR-AA-ADS and P4TR-AB-ADS) for indoor use.
2025-12-04
Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG - The PC Client software is an accessory to the Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III and Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV. The PC Client application allows managing the recording sessions and reviewing the ECG data that was recorded by the patient monitors.
2017-12-18
DeepRhythmAI - The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices.
2022-08-05
PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System - The PocketECG transmitter is a key component of PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-III is inteded for use in GSM cellular networks.
2018-01-09
PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System - The PocketECG transmitter is a key component of the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-IIIV is inteded for use in CDMA cellular networks.
2018-01-09
PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System - The battery type PECGB-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter.
2018-01-09
PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System - The battery charger type PECGC-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the PECGB-III batteries used with PocketECG transmitter.
2018-01-09
PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation System - The PocketECG CRS transmitter type PECGT-IIIR is a key component of PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG CRS transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. The PocketECG CRS is inteded for use in GSM cellular networks.
2018-08-21
DeepRhythm Platform - The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of:• enrolling a patient for an ECG monitoring session in a medical facility,• receiving the signal from a compatible monitoring device worn by the patient,• using an external AI service for signal analysis and classification,• processing signal and annotations received from the external AI service, including statistics computation,• reviewing the signal and annotations by an ECG Technician,• generating and publishing reports for single ECG episodes and the entire monitoring session as well,• reviewing published reports back at the medical facility that ordered the monitoring session in the first place.
2024-12-20
Q Patch - The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient’s ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch’s memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
2022-06-23
Q Patch Mobile Application - Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with the Q Patch recorder for transmission patient data to set up ECG recording session and displaying the Q Patch’s status. The application is obligatory for healthcare professionals and optional for patients
2022-06-23
Q Patch Downloader - Q Patch Downloader (PC application) – The intended use of the Q Patch Downloader application is to download the data from completed Q Patch session and upload files containing ECG data to the predefine storage space.
2022-06-23
PocketECG IV – Unified Arrhythmia Diagnostic System - The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AA-ADS is inteded for use in LTE cellular networks.
2020-08-14
PocketECG IV – Unified Arrhythmia Diagnostic System - The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AB-ADS is inteded for use in LTE cellular networks.
2020-08-14
PocketECG IV – Unified Arrhythmia Diagnostic System - The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter.
2020-08-14
PocketECG IV – Unified Arrhythmia Diagnostic System - The battery charger type P3CH-AB-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the P4BA-AA-UNI or P4BA-AB-UNI batteries used with PocketECG transmitter.
2020-08-14
PocketECG IV – Unified Arrhythmia Diagnostic System - The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter.
2020-08-14
PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System - The holster type PECGH-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. It is a belt holder for PocketECG transmitters (types PECGT-III or PECGT-IIIV) for indoor use.
2018-08-21