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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K091529
Device Name ICAD VERALOOK CTC CAD SOFTWARE
Applicant
Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua,  NH  03062
Applicant Contact JOHN A DELUCIA
Correspondent
Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua,  NH  03062
Correspondent Contact JOHN A DELUCIA
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/22/2009
Decision Date 08/04/2010
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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