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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
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