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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 K112974
Device Name PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Applicant
Curve Dental, Inc.
424 W. 800 N. Suite 202
Orem,  UT  84057
Applicant Contact GEORGE STANTCHEV
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/05/2011
Decision Date 10/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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