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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 K071636
Device Name CODIAGNOSTIX (R) 5.72
Applicant
IVS SOLUTIONS AG
ANNABERGET STRASSE 240
CHEMNITZ, SAXONY,  DE 09125
Applicant Contact FRANK STOCKMANN
Correspondent
IVS SOLUTIONS AG
ANNABERGET STRASSE 240
CHEMNITZ, SAXONY,  DE 09125
Correspondent Contact FRANK STOCKMANN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/15/2007
Decision Date 08/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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