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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 K032924
Device Name RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
Applicant
Volume Interactions Pte, Ltd.
5 Shenton Way
#37-04 Uic Bldg.
Singapore,  SG
Applicant Contact JOHN BABY
Correspondent
Volume Interactions Pte, Ltd.
5 Shenton Way
#37-04 Uic Bldg.
Singapore,  SG
Correspondent Contact JOHN BABY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/22/2003
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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