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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 K101654
Device Name IMPROVIS IMAGING SYSTEM
Applicant
American Dental Partners, Inc.
401 Edgewater Pl.
Suite 430
Wakefield,  MA  01880
Applicant Contact TIMOTHY RODENBERGER
Correspondent
American Dental Partners, Inc.
401 Edgewater Pl.
Suite 430
Wakefield,  MA  01880
Correspondent Contact TIMOTHY RODENBERGER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/11/2010
Decision Date 11/10/2010
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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