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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 K231955
Device Name aprevo® Digital Segmentation
Applicant
Carlsmed, Inc.
1800 Aston Ave. Suite 100
San Diego,  CA  92008
Applicant Contact Karen Liu
Correspondent
Carlsmed, Inc.
1800 Aston Ave. Suite 100
San Diego,  CA  92008
Correspondent Contact Karen Liu
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/03/2023
Decision Date 11/03/2023
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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