QLAB WITH FHN AND VPQ PLUG-IN


Device Classification Name

system, image processing, radiological

510(k) Number K121223
Device Name QLAB WITH FHN AND VPQ PLUG-IN
Applicant
PHILIPS ULTRASOUND, INC.
3000 minuteman rd.
andover, 
MA 
01810

Applicant Contact penny greco
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/23/2012
Decision Date 05/15/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No