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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K242188
Device Name ClearRead CT CAC
Applicant
Riverain Technologies, Inc.
3130 South Tech Boulevard
Miamisburg,  OH  45342
Applicant Contact Jonathan Jackson
Correspondent
Riverain Technologies, Inc.
3130 South Tech Boulevard
Miamisburg,  OH  45342
Correspondent Contact Jonathan Jackson
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/25/2024
Decision Date 12/03/2024
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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