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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 Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K212783
Device Name ProstatID
Applicant
ScanMed, LLC
9840 S 140 Street, Suite #8
Omaha,  NE  68138
Applicant Contact Randall Jones
Correspondent
ScanMed, LLC
9840 S 140 Street, Suite #8
Omaha,  NE  68138
Correspondent Contact Carlee Seeba
Classification Product Code
QDQ  
Date Received09/01/2021
Decision Date 07/08/2022
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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