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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 K033637
Device Name MEDICAL IMAGE DIGITIZER, MODEL 2908
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 Received11/19/2003
Decision Date 12/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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