QXD — Spinal Imaging System For Neuraxial Procedures Class II
FDA product code QXD covers "Spinal Imaging System For Neuraxial Procedures", a Class II medical device regulated under 21 CFR 868.1985. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXD
- Device Class
- Class II
- Regulation Number
- 868.1985
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220009 | intuitap medical | VerTouch Spinal Imaging Device | January 19, 2024 |