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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K213760
Device Name ABMD Software
Applicant
HeartLung Corporation
1124 W Carson St
Torrance,  CA  90502
Applicant Contact Morteza Naghavi
Correspondent
HeartLung Corporation
1124 W Carson St
Torrance,  CA  90502
Correspondent Contact Lauren Lee
Regulation Number892.1170
Classification Product Code
KGI  
Date Received12/01/2021
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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