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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K213660
Device Name RadAlly
Applicant
Imaging Wave, LLC
7023 Juno St.
Forrest Hills,  NY  11375
Applicant Contact Edward Kantor
Correspondent
Imaging Wave, LLC
7023 Juno St.
Forrest Hills,  NY  11375
Correspondent Contact Edward Kantor
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/22/2021
Decision Date 03/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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