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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 K122329
Model REV. 1.0
Device Name BIOJET
Original Applicant
JET SOFT SRL
str. anasttasie panu nr. 6
bucharest,  RO 031164
Original Contact peter-m klews
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/01/2012
Decision Date 08/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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