Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007770164

FEI Number

3007770164

Entity Name

MEDICALGORITHMICS S.A.

City/State/Country

WARSAW Mazowieckie, PL

Establishment Address

AL. JEROZOLIMSKIE 81, WARSAW Mazowieckie 02-001, PL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Medicalgorithmics S.A. (Owner Number: 10029709)

Owner / Operator Contact Address

Al. Jerozolimskie 81, VAT ID:521-336-14-57, WARSAW, PL-14 02-001, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210758

PMA Number

N/A

All Registered Proprietary Names

DeepRhythmAI Unified Arrhythmia Diagnostic System PocketECG IV DeepRhythmAI Q Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-12-15
QYX	Outpatient Cardiac Telemetry	Cardiovascular	Class 2	870.1025	2025-12-15
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-12-15
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2020-06-16
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-05-29
QYX	Outpatient Cardiac Telemetry	Cardiovascular	Class 2	870.1025	2025-05-29
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-05-29
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2022-06-20

Official Correspondent

Michal Zapora

US Agent Details

Joanna Dabala Business: Medicalgorithmics US Holding Corporation Email: j.dabala@medicalgorithmics.com Phone: (302) 2615184

Related Public Records

Same Entity

Medicalgorithmics S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

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3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
3003084417	STEREOTAXIS, INC.	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007770164. Last updated year: 2026. Please use registration number 3007770164 when referencing this establishment in official correspondence.