Spinal Imaging System For Neuraxial Procedures

QXD · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1985

Classification

FDA Product Code: QXD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.1985
Review panel: AN
Medical specialty: Anesthesiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown