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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 K951175
Device Name MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS)
Applicant
Sirius Corp.
4701 Sangamore Rd.,
Suite 205 S.
Bethesda,  MD  20816
Applicant Contact DANIEL CAROZZA
Correspondent
Sirius Corp.
4701 Sangamore Rd.,
Suite 205 S.
Bethesda,  MD  20816
Correspondent Contact DANIEL CAROZZA
Regulation Number892.2020
Classification Product Code
LMD  
Date Received03/15/1995
Decision Date 06/30/1995
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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