FDA.reportPublic FDA data

MEDICALGORITHMICS S.A.

Matched from indexed company URL: Medicalgorithmics S.A.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077701643007770164MEDICALGORITHMICS S.A.1N2026-01-01AL. JEROZOLIMSKIE 81 WARSAW Mazowieckie PL 02-001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1051901369660057K253141DeepRhythmAIDQK2025-12-11
1051901603992246K250932DeepRhythmAIDQK2025-05-27
1051901212965148K232161DeepRhythm PlatformDPS2024-06-20
1051901265972314K210758Q PatchMWJ2022-06-02
1051901691922826K193104Unified Arrhythmia Diagnostic System PocketECG IVDSI2020-04-09
1051901556763853K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemDSI2018-07-11
1051901030807962K152550MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEMDSI2015-10-08
1051901797604269K124060MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEMDSI2013-02-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSI42020-04-09
DQK22025-12-11
DPS12024-06-20
MWJ12022-06-02

PMN#

Q Patch

2022-06-02

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.

MEDICALGORITHMICS S A

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.

MEDICALGORITHMICS S A

2025-06-06

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.

MEDICALGORITHMICS S A

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.

MEDICALGORITHMICS S A

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.

MEDICALGORITHMICS S A

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.

MEDICALGORITHMICS S A

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).

MEDICALGORITHMICS S A

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.

MEDICALGORITHMICS S A

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.

MEDICALGORITHMICS S A

2020-08-14