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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 BUILDING
SINGAPORE,  SG
Applicant Contact JOHN BABY
Correspondent
VOLUME INTERACTIONS PTE LTD
5 SHENTON WAY
#37-04 UIC BUILDING
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
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