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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 K954055
Device Name HDX DIGITAL IMAGING SYSTEM
Applicant
Imacom, Inc.
2092 Gaither Rd., Suite 220
Rockville,  MD  20850
Applicant Contact JASON CHOU
Correspondent
Imacom, Inc.
2092 Gaither Rd., Suite 220
Rockville,  MD  20850
Correspondent Contact JASON CHOU
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/29/1995
Decision Date 10/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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