510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220009Unknown

VerTouch Spinal Imaging Device

Intuitap Medical, Inc, Houston TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN220009 is the FDA 510(k) clearance record for VerTouch Spinal Imaging Device, a class II device, cleared for Intuitap Medical, Inc. on under FDA product code QXD (Spinal Imaging System For Neuraxial Procedures). FDA's definition for product code QXD reads: "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". FDA records list one 510(k) clearance for Intuitap Medical, Inc. As of , FDA records show no recalls naming DEN220009.

Clearance record

Decision date
Received
(717 days to decision)
Product code
QXD Spinal Imaging System For Neuraxial Procedures
Regulation
21 CFR 868.1985
Device class
Class II
Review panel
Anesthesiology
Applicant
Intuitap Medical, Inc. 1940 Fountain View Dr., Houston TX
Third party review
No

Clearances, product code QXD

Trailing 12 months

FDA records hold no clearances under product code QXD in the trailing twelve months.

FDA records show no clearances under product code QXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260