VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3


Device Classification Name

system, image processing, radiological

510(k) Number K022938
Device Name VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3
Original Applicant
VOLUME INTERACTIONS PTE LTD
5 shenton way
#37-04 uic building
singapore, 

SG

Original Contact john baby
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/04/2002
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