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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 K950343
Device Name HYPERPACS PACS AND TELERAFIOLOGY SYSTEM
Applicant
Rogan Imaging Corp.
S20 W27872 Kame Ter.
Waukesha,  WI  53188
Applicant Contact MARK L SCHWARTZ
Correspondent
Rogan Imaging Corp.
S20 W27872 Kame Ter.
Waukesha,  WI  53188
Correspondent Contact MARK L SCHWARTZ
Regulation Number892.2020
Classification Product Code
LMD  
Date Received01/27/1995
Decision Date 04/12/1995
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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