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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 K244002
Device Name AngioWaveNet
Applicant
Angiowave Imaging, Inc.
82 Alden Rd.
Concord,  MA  01742
Applicant Contact Aram Salzman
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
OWB  
Date Received12/26/2024
Decision Date 09/10/2025
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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