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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 K022938
Device Name VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM 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 Received09/04/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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