Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

QXD

Spinal Imaging System For Neuraxial Procedures

Product code
QXD
Device name
Spinal Imaging System For Neuraxial Procedures
Device class
Class 2
21 CFR
21 CFR 868.1985
Medical specialty
Anesthesiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-01-19.

NumberDecision dateApplicantDevice nameSummary
DEN2200092024-01-19Intuitap Medical, Inc.VerTouch Spinal Imaging Device—
Official FDA classification page: QXD
Classification and pathway per current FDA publications. Data from openFDA (CC0).