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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 K024103
Device Name IVUS PLUS
Applicant
Indec Systems, Inc.
505 E. Evelyn
Suite D
Mountain View,  CA  94041
Applicant Contact CAROL HUBLER
Correspondent
Indec Systems, Inc.
505 E. Evelyn
Suite D
Mountain View,  CA  94041
Correspondent Contact CAROL HUBLER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/12/2002
Decision Date 01/24/2003
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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