RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3


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

Correspodent Contact john baby
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/22/2003
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