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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K040227
Device Name QLAB QUANTIFICATION SOFTWARE
Applicant
Philips Ultrasound
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact STEVE SINGLAR
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/02/2004
Decision Date 02/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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