Spinal Imaging System For Neuraxial Procedures
The spinal imaging system for neuraxial procedures (product code QXD) is a Class 2 Anesthesiology device (regulation 868.1985) consisting of a sensor and software system used to assist in the identification of the interspinous space for neuraxial procedures such as epidural or spinal anesthesia. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXD
- Device Class
- FDA class 2
- Regulation Number
- 868.1985
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220009 | VerTouch Spinal Imaging Device | Jan 19, 2024 | Unknown | Intuitap Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.