DeviceClearance

Product code QXD— Anesthesiology

VerTouch Spinal Imaging Device

Classification name
Spinal Imaging System For Neuraxial Procedures
Device class
Class 2
Regulation
21 CFR 868.1985
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QXD under 21 CFR 868.1985, via openFDA

Market context for product code QXD

FDA has cleared 1 device under product code QXD, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXD

Recent clearances under product code QXD

Data sourced from openFDA. This site is unofficial and independent of the FDA.