PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300


Device Classification Name

system, image processing, radiological

510(k) Number K080320
Device Name PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
Applicant
NDS SURGICAL IMAGING
5750 hellyer avenue
san jose, 
CA 
95138

Applicant Contact jim lang
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/06/2008
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No