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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K971894
Device Name KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact JUDITH A WALLACE
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact JUDITH A WALLACE
Regulation Number892.2030
Classification Product Code
LMA  
Date Received05/22/1997
Decision Date 08/20/1997
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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