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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K241607
Device Name MyoStrain (6.0)
Applicant
Myocardial Solutions, Inc.
808 Aviation Pkwy. Suite 700
Morrisville,  NC  27560
Applicant Contact Linda Home
Correspondent
Myocardial Solutions, Inc.
808 Aviation Pkwy. Suite 700
Morrisville,  NC  27560
Correspondent Contact Linda Home
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/04/2024
Decision Date 08/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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