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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
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