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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 K063730
Device Name DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
Applicant
Volume Interactions Pte, Ltd.
1 Kim Seng Promenade
#12-01 Great World City E.
Tower, Singapore,  SG 237994
Applicant Contact VALERIE FAN
Correspondent
Volume Interactions Pte, Ltd.
1 Kim Seng Promenade
#12-01 Great World City E.
Tower, Singapore,  SG 237994
Correspondent Contact VALERIE FAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/18/2006
Decision Date 01/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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