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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 TERRACE
WAUKESHA,  WI  53188 -5232
Applicant Contact MARK L SCHWARTZ
Correspondent
ROGAN IMAGING CORP.
S20 W27872 KAME TERRACE
WAUKESHA,  WI  53188 -5232
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
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