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FDA 510(k)

Myocardial Strain Software Application

K-Number: K232661 · 2023-12-07

ApplicantCircle Cardiovascular Imaging
Decision Date2023-12-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Myocardial Strain Software Application is a medical device manufactured by Circle Cardiovascular Imaging. It received FDA 510(k) clearance on 2023-12-07 under approval number K232661. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Myocardial Strain Software Application?

Myocardial Strain Software Application is a medical device that received FDA 510(k) clearance on 2023-12-07. It is manufactured by Circle Cardiovascular Imaging. The 510(k) number is K232661.

When was Myocardial Strain Software Application approved by the FDA?

Myocardial Strain Software Application received FDA 510(k) clearance on 2023-12-07, under approval number K232661.

What company makes Myocardial Strain Software Application?

Myocardial Strain Software Application is manufactured by Circle Cardiovascular Imaging.

What is the FDA product code for Myocardial Strain Software Application?

The FDA product code for Myocardial Strain Software Application is LLZ.

Related Clinical Trials

NCT01220349 Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy COMPLETED NCT01212926 Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain COMPLETED NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT07084779 Investigation of Impact of AI on Prostate Cancer Workflow RECRUITING NCT06257069 Tremor Retrainer Software Application for Functional Tremor ACTIVE_NOT_RECRUITING NCT06366867 An Open Platform of Serious Games for Cognitive Intervention COMPLETED

Related PubMed Literature

PMID: 39698124 Advancements in Clinical Evaluation and Regulatory Frameworks for AI-Driven Software as a Medical Device (SaMD). IEEE open journal of engineering in medicine and biology (2025) PMID: 25644202 Regulatory frameworks for mobile medical applications. Expert review of medical devices (2015)

Other Devices by Circle Cardiovascular Imaging

K241038Cardiac CT Function Software Application

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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