Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN


Device Classification Name

system, image processing, radiological

510(k) Number K023877
Device Name Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
Original Applicant
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy.
bothell, 
WA 
98041 -3003

Original Contact lynn harmer
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/21/2002
Decision Date 12/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No