UNIVERSAL SYSTEM, MODEL QV-800


Device Classification Name

system, x-ray, stationary

510(k) Number K023008
Device Name UNIVERSAL SYSTEM, MODEL QV-800
Original Applicant
QUANTUM MEDICAL IMAGING, LLC.
2905 veterans memorial highway
ronkonkoma, 
NY 
11779

Original Contact mark camirand
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 09/09/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No