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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 K071492
Device Name FIRSTVIEW
Applicant
Riverain Medical Group,Llc
3020 S. Tech Blvd.
Miamisburg,  OH  45342 -4860
Applicant Contact JENNIFER STEINKE
Correspondent
Riverain Medical Group,Llc
3020 S. Tech Blvd.
Miamisburg,  OH  45342 -4860
Correspondent Contact JENNIFER STEINKE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/30/2007
Decision Date 08/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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