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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 K011196
Device Name IQUANTIFY, VERSION 1.0
Applicant
Insightful Corporation
1700 Westlake Ave.
Suite 500
Seattle,  WA  98109
Applicant Contact BRADLEY T WYMAN
Correspondent
Insightful Corporation
1700 Westlake Ave.
Suite 500
Seattle,  WA  98109
Correspondent Contact BRADLEY T WYMAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/19/2001
Decision Date 11/08/2001
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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