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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 K121075
Device Name NERVEVISION SOFTWARE SYSTEMS
Applicant
3D IMAGING PARTNERS INC.
7046 OWL'S NEST TERRACE
BRADENTON,  FL  34203
Applicant Contact CAROLYN PRIMUS
Correspondent
3D IMAGING PARTNERS INC.
7046 OWL'S NEST TERRACE
BRADENTON,  FL  34203
Correspondent Contact CAROLYN PRIMUS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/09/2012
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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