Medicalgorithmics S.A.
WARSAW Mazowieckie, PL
MEDICALGORITHMICS S.A. appears in FDA device records in WARSAW Mazowieckie, PL. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Medicalgorithmics S.A. between 2012 and 2025. The busiest year on record is 2022, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253141 | DeepRhythmAI | DQK | Substantially Equivalent | |
| K250932 | DeepRhythmAI | DQK | Substantially Equivalent | |
| K241197 | DeepRhythmAI | DQK | Substantially Equivalent | |
| K232161 | DeepRhythm Platform | DPS | Substantially Equivalent | |
| K210822 | DeepRhythmAI | DQK | Substantially Equivalent | |
| K210758 | Q Patch | MWJ | Substantially Equivalent | |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | DSI | Substantially Equivalent | |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | DSI | Substantially Equivalent | |
| K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | DSI | Substantially Equivalent | |
| K124060 | MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | DSI | Substantially Equivalent | |
| K112921 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | DSI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007770164 | 3007770164 | MEDICALGORITHMICS S.A. | AL. JEROZOLIMSKIE 81, WARSAW Mazowieckie 02-001 PL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain