QLAB 8.1 QUANTIFICATION SOFTWARE


Device Classification Name

system, image processing, radiological

510(k) Number K110414
Device Name QLAB 8.1 QUANTIFICATION SOFTWARE
Applicant
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy.
bothell, 
WA 
98021

Applicant Contact nancy burke
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/14/2011
Decision Date 06/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No