# DEN220009: VerTouch Spinal Imaging Device

- Pathway: De Novo (Direct)
- Applicant: Intuitap Medical, Inc.
- Decided: Jan 19, 2024 after 717 days
- Product code: QXD (Spinal Imaging System For Neuraxial Procedures)
- Device class: 2
- Regulation: 21 CFR 868.1985
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
VerTouch is indicated to aid in the localization of a lumbar interspinous space, and the marking of an identified insertion site, for diagnostic and therapeutic neuraxial procedures. VerTouch is indicated for use in hospital facilities and clinics by right- and left-handed emergency medicine, neurology, anesthesiology, and pain medicine professionals for assistance with spinal punctures. The VerTouch handle is intended to be held with the left hand. Imaging and marking are intended to be performed with the right hand. VerTouch is indicated for use on patients at least 18 years of age with BMI ≤42 kg/m2 undergoing the following procedures in the seated or lateral positions: • Lumbar punctures • Neuraxial anesthesia (spinals, epidurals, and combined spinal-epidurals) • Epidural steroid injections • Epidural blood patches VerTouch can only be used with the marker included in the VerTouch Kit.

Source page: https://510kreport.com/device/DEN220009
Methodology: https://510kreport.com/methodology