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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K221612
Device Name ClearRead CT
Applicant
Riverain Technologies, Inc.
3130 S. Tech Blvd.
Miamisburg,  OH  45342
Applicant Contact Jonathan Jackson
Correspondent
Riverain Technologies, Inc.
3130 S. Tech Blvd.
Miamisburg,  OH  45342
Correspondent Contact Jonathan Jackson
Regulation Number892.2050
Classification Product Code
OEB  
Subsequent Product Code
LLZ  
Date Received06/03/2022
Decision Date 12/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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