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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K213566
Device Name ClearRead Xray Pneumothorax
Applicant
Riverain Technologies, Inc.
3020 South Tech Blvd.
Miamisburg,  OH  45342 -4860
Applicant Contact Jonathan Jackson
Correspondent
Riverain Technologies, Inc.
3020 South Tech Blvd.
Miamisburg,  OH  45342 -4860
Correspondent Contact Jonathan Jackson
Regulation Number892.2080
Classification Product Code
QFM  
Date Received11/09/2021
Decision Date 03/10/2022
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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