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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 K240417
Device Name ProFound Detection (V4.0)
Applicant
Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua,  NH  03062
Applicant Contact Spence Hartwell
Correspondent
Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua,  NH  03062
Correspondent Contact Spence Hartwell
Classification Product Code
QDQ  
Date Received02/13/2024
Decision Date 11/08/2024
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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