Q-STATION


Device Classification Name

system, image processing, radiological

510(k) Number K103815
Device Name Q-STATION
Applicant
PHILIPS ULTRASOUND, INC.
p.o. box 3003
bothell, 
WA 
98021 -3003

Applicant Contact nancy p burke
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 12/29/2010
Decision Date 01/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No