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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 K092581
Device Name MITS DICOM GATEWAY AND IMAGE MANAGER
Applicant
Mitsmed Medical Instrument Technology Co., Ltd.
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Applicant Contact Ke-Min Jen
Correspondent
Mitsmed Medical Instrument Technology Co., Ltd.
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/21/2009
Decision Date 10/30/2009
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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