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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name spinal imaging system for neuraxial procedures
De Novo Number DEN220009
Device Name VerTouch Spinal Imaging Device
Requester
intuitap medical, inc.
1940 fountain view dr.
houston,  TX  77057
Contact jessica traver
Regulation Number868.1985
Classification Product Code
QXD  
Date Received02/01/2022
Decision Date 01/19/2024
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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