DIGIVIEW 250


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K103348
Device Name DIGIVIEW 250
Applicant
KUB TECHNOLOGIES, INC
270 rowe avenue
suite e
milford, 
CT 
06460

Applicant Contact vikram butani
Correspondent
KUB TECHNOLOGIES, INC
270 rowe avenue
suite e
milford, 
CT 
06460

Correspodent Contact vikram butani
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 11/15/2010
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No