Cleared Traditional

DeepRhythmAI

K241197 · Medicalgorithmics S.A. · Cardiovascular
Dec 2024
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K241197 is an FDA 510(k) clearance for the DeepRhythmAI, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on December 4, 2024, 218 days after receiving the submission on April 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K241197 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2024
Decision Date December 04, 2024
Days to Decision 218 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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