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U.S. Department of Health and Human Services

510(k) Premarket Notification

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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

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Device Classification Name system, tomography, computed, emission
510(k) Number K051855
Device Name VENTRI
Original Applicant
4 hayozma st.
tirat hacarmel,  IS 30200
Original Contact eli werner
Regulation Number892.1200
Classification Product Code
Date Received07/08/2005
Decision Date 08/02/2005
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
Recalls CDRH Recalls