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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 K012093
Device Name AETMED IMAGE PROCESSING SOFTWARE
Applicant
Aetmed, S.P.A.
7992 Castleway Dr.
Indianpolis,  IN  46250
Applicant Contact COLLEEN HITTLE
Correspondent
Aetmed, S.P.A.
7992 Castleway Dr.
Indianpolis,  IN  46250
Correspondent Contact COLLEEN HITTLE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/05/2001
Decision Date 09/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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