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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 K953193
Device Name SCINTRON IV
Applicant
Medical Imaging Electronics America, Inc.
2340 Brickvale
Elk Grove Village,  IL  60007
Applicant Contact JOHN H LOEBEL
Correspondent
Medical Imaging Electronics America, Inc.
2340 Brickvale
Elk Grove Village,  IL  60007
Correspondent Contact JOHN H LOEBEL
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/10/1995
Decision Date 10/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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