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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 K061035
FOIA Releasable 510(k) K061035
Device Name TIGERVIEW PROFESSIONAL
Applicant
Televere Systems
6304 Belmont Circle Bldg. 2
Mount Airy,  MD  21771
Applicant Contact MELISSA MAHALL
Correspondent
Televere Systems
6304 Belmont Circle Bldg. 2
Mount Airy,  MD  21771
Correspondent Contact MELISSA MAHALL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/14/2006
Decision Date 06/05/2006
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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