FDA product code QXD: Spinal Imaging System For Neuraxial Procedures
QXD is the FDA product code for spinal imaging system for neuraxial procedures. It is a Class II device, regulated under 21 CFR 868.1985 and reviewed by the Anesthesiology panel. Devices under QXD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Spinal Imaging System For Neuraxial Procedures |
| Device class | Class II |
| Regulation | 21 CFR 868.1985 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Recalls for QXD devices
openFDA lists no recalls for product code QXD.
Frequently asked questions
What is FDA product code QXD?
QXD is the FDA product code for spinal imaging system for neuraxial procedures. It is a Class II device, regulated under 21 CFR 868.1985 and reviewed by the Anesthesiology panel.
What device class is QXD?
Class II, regulation 21 CFR 868.1985. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXD
- Run a recall and safety report across every QXD manufacturer
- Watch product code QXD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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