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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K101013
Device Name MODIFICATION TO SCINTRON IV
Applicant
Miegmbh
420 Bennett Rd.
Elk Grove Village,  IL  60007
Applicant Contact NORMAN VON HOLLEN
Correspondent
Miegmbh
420 Bennett Rd.
Elk Grove Village,  IL  60007
Correspondent Contact NORMAN VON HOLLEN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received04/12/2010
Decision Date 06/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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