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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K042697
Device Name SECOND LOOK VIEWER
Applicant
ICAD INC.
2689 COMMONS BLVD., SUITE 100
BEAVERCREEK,  OH  45431
Applicant Contact JOHN ROSENSTENGEL
Correspondent
ICAD INC.
2689 COMMONS BLVD., SUITE 100
BEAVERCREEK,  OH  45431
Correspondent Contact JOHN ROSENSTENGEL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/30/2004
Decision Date 11/19/2004
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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