De Novo · Granted
GrantedVerTouch Spinal Imaging Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitap Medical, Inc. · QXD Spinal Imaging System For Neuraxial Procedures
Granted on Jan 19, 2024 as a new device type through De Novo after a 717-day review.
- Decided
- Jan 19, 2024
- Review
- 717 days
- Class
- Class II
- Product code
- QXD
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QXD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QXD devicesQXD Spinal Imaging System For Neuraxial Procedures: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QXD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QXD
Too few QXD 510(k)s in any year since 2007 to give a median.
Recalls per year · QXD
No recall names QXD since 2007.
Adverse event reports per year · QXD
No MAUDE report names QXD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.…
Read the full statement (137 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220009 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220009: VerTouch Spinal Imaging Device.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026