Data / Medical devices / Poland / Medicalgorithmics S.A.
Medicalgorithmics S.A.: FDA-registered device maker in WARSAW Mazowieckie, Poland, 5 510(k) clearances
Medicalgorithmics S.A. is registered with the FDA (registration 3007770164) in WARSAW Mazowieckie, Poland. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007770164
- Address
- Al. Jerozolimskie 81, WARSAW Mazowieckie, Poland, 02-001
- Owner or operator
- Medicalgorithmics S.A. (10029709)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 16, 2020
- Registered through
- 2026
- Brand names listed
- DRP, DeepRhythm Platform, DeepRhythmAI, Q Patch, Unified Arrhythmia Diagnostic System PocketECG IV
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Detector And Alarm, Arrhythmia | DSI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Outpatient Cardiac Telemetry | QYX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2025 | K253141 | DeepRhythmAI | DQK | Substantially Equivalent | Medicalgorithmics S.A. | accessdata.fda.gov |
| May 27, 2025 | K250932 | DeepRhythmAI | DQK | Substantially Equivalent | Medicalgorithmics S.A. | accessdata.fda.gov |
| June 20, 2024 | K232161 | DeepRhythm Platform | DPS | Substantially Equivalent | Medicalgorithmics S.A. | accessdata.fda.gov |
| June 2, 2022 | K210758 | Q Patch | MWJ | Substantially Equivalent | Medicalgorithmics S.A. | accessdata.fda.gov |
| April 9, 2020 | K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | DSI | Substantially Equivalent | Medicalgorithmics S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph
- All makers of Outpatient Cardiac Telemetry
- All makers of Detector And Alarm, Arrhythmia
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
Updated December 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.