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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 K071054
Device Name RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
Applicant
Volume Interactions Pte, Ltd.
1 Kim Seng Promenade
#12-01 Great World City E.
Tower, Singapore,  SG 237994
Applicant Contact MICHAEL SIM
Correspondent
Volume Interactions Pte, Ltd.
1 Kim Seng Promenade
#12-01 Great World City E.
Tower, Singapore,  SG 237994
Correspondent Contact MICHAEL SIM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/16/2007
Decision Date 05/22/2007
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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