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510(k) K241197

DeepRhythmAI by Medicalgorithmics S.A. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2024
Date Received
April 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Medicalgorithmics S.A.

  • K253141 — DeepRhythmAI (December 11, 2025)
  • K250932 — DeepRhythmAI (May 27, 2025)
  • K232161 — DeepRhythm Platform (June 20, 2024)
  • K210822 — DeepRhythmAI (July 27, 2022)
  • K210758 — Q Patch (June 2, 2022)
  • K193104 — Unified Arrhythmia Diagnostic System PocketECG IV (April 9, 2020)
  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)
  • K152550 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM (October 8, 2015)
  • K124060 — MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (February 21, 2013)
  • K112921 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (May 16, 2012)

Other clearances for product code DQK

  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)