De Novo DEN220009

Device
VerTouch Spinal Imaging Device
Contact
jessica traver
De Novo number
DEN220009
Product code
QXD
Regulation
868.1985
Classification name
spinal imaging system for neuraxial procedures
Decision
granted (DENG)
Decision date
2024-01-19
Date received
2022-02-01
Classification advisory
Anesthesiology
Review advisory
Anesthesiology
Type
Direct

Current FDA Classification#

Product code
QXD
Device name
Spinal Imaging System For Neuraxial Procedures
Medical specialty
Anesthesiology
Device class
2
Regulation
868.1985
Implant
N
Life sustain/support
N