QXD · Class II · 21 CFR 868.1985

FDA Product Code QXD: Spinal Imaging System For Neuraxial Procedures

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.

Leading manufacturers include Intuitap Medical, Inc..

1
Total
0
Cleared
717d
Avg days
2024
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Spinal Imaging System For Neuraxial Procedures Devices (Product Code QXD)

1 devices
1–1 of 1

About Product Code QXD - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXD since 2024, with 0 receiving FDA clearance (average review time: 717 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXD devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →