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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Cardiac Amyloidosis Status Indicator
510(k) Number K243866
Device Name InVision Precision Cardiac Amyloid
Applicant
InVision Medical Technology Corporation
9702 Cisco St.
Los Angeles,  CA  90034
Applicant Contact David Ouyang
Correspondent
InVision Medical Technology Corporation
9702 Cisco St.
Los Angeles,  CA  90034
Correspondent Contact Golnaz Moeini
Regulation Number870.2200
Classification Product Code
SDJ  
Date Received12/17/2024
Decision Date 05/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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