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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 K093444
Device Name EXAPACS
Applicant
Medincom Technology Corp
B1, #207-1, Sec.3, Beisin Rd.
Sindian City
Taipei Hsien,  TW 231
Applicant Contact ANDREW LEE
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC MOUSER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/05/2009
Decision Date 02/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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