Product code QXD

Device name
Spinal Imaging System For Neuraxial Procedures
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.1985
Review panel
AN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures.
Source
FDA openFDA device classification dataset

Related 510(k) Records

510(k)DeviceApplicantDecision date
DEN220009VerTouch Spinal Imaging DeviceIntuitap Medical, Inc.2024-01-19