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