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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K922164
Device Name RAYTEL DIGITAL IMAGING SYSTEMS
Applicant
Olicon Imaging Systems, Inc.
1011 Calle Amanecer
San Clemente,  CA  92673
Applicant Contact R. L PAULSEN
Correspondent
Olicon Imaging Systems, Inc.
1011 Calle Amanecer
San Clemente,  CA  92673
Correspondent Contact R. L PAULSEN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received05/08/1992
Decision Date 01/21/1993
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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