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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Digital Image Manual Interpretation Microscope
510(k) Number K130021
Device Name PHILIPS HERCEPTEST DIGITAL SCORE
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact DIRK VOSSEN
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact DIRK VOSSEN
Regulation Number864.1860
Classification Product Code
OEO  
Date Received01/03/2013
Decision Date 09/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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