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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K232331
Device Name InVision Precision LVEF (LVEF)
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 Number892.2050
Classification Product Code
QIH  
Date Received08/04/2023
Decision Date 04/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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