QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI


Device Classification Name

system, image processing, radiological

510(k) Number K080905
Device Name QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
Applicant
QUANTUM MEDICAL IMAGING, LLC.
5 whitcomb avenue
ayer, 
MA 
01432 -7661

Applicant Contact pamela papineau
Correspondent
QUANTUM MEDICAL IMAGING, LLC.
5 whitcomb avenue
ayer, 
MA 
01432 -7661

Correspodent Contact pamela papineau
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/01/2008
Decision Date 07/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No