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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 K052537
Device Name CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
Applicant
American Medical Sales, Inc.
4928 W. Rosecrans Ave.
Hawthorne,  CA  90250
Applicant Contact CAROL M LIFLAND
Correspondent
American Medical Sales, Inc.
4928 W. Rosecrans Ave.
Hawthorne,  CA  90250
Correspondent Contact CAROL M LIFLAND
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/15/2005
Decision Date 11/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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