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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 K063424
Device Name FILM DIGITZER, MODEL 2908 MAMMO PRO
Applicant
Array Corp.
3-42-10 Yoyogi, Shibuya-Ku
Tokyo,  JP 151-0053
Applicant Contact TAKASHI INAMI
Correspondent
Array Corp.
3-42-10 Yoyogi, Shibuya-Ku
Tokyo,  JP 151-0053
Correspondent Contact TAKASHI INAMI
Regulation Number892.2030
Classification Product Code
LMA  
Date Received11/13/2006
Decision Date 12/21/2006
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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