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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 K070954
Device Name PATIENTGALLERY IMAGING SOFTWARE
Applicant
Raster Builders, Inc.
38 Miller Ave. Pmb 170
Mill Valley,  CA  94941
Applicant Contact DAVID L STARK
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131 -1230
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/05/2007
Decision Date 04/20/2007
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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