DeepRhythmAI
K-Number: K250932 · 2025-05-27
ApplicantMedicalgorithmics S.A.
Decision Date2025-05-27
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
DeepRhythmAI is a medical device manufactured by Medicalgorithmics S.A.. It received FDA 510(k) clearance on 2025-05-27 under approval number K250932. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DeepRhythmAI?
DeepRhythmAI is a medical device that received FDA 510(k) clearance on 2025-05-27. It is manufactured by Medicalgorithmics S.A.. The 510(k) number is K250932.
When was DeepRhythmAI approved by the FDA?
DeepRhythmAI received FDA 510(k) clearance on 2025-05-27, under approval number K250932.
What company makes DeepRhythmAI?
DeepRhythmAI is manufactured by Medicalgorithmics S.A..
What is the FDA product code for DeepRhythmAI?
The FDA product code for DeepRhythmAI is DQK.
Other Devices by Medicalgorithmics S.A.
Related Devices (Code: DQK)
K160218AutoMark ModuleSt Jude Medical
K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical
K162643MediGuide Technology SystemSt Jude Medical
K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.
K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical
K160186EnSite Velocity Surface Electrode KitSt Jude Medical
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.