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510(k) DEN220009

VerTouch Spinal Imaging Device by Intuitap Medical, Inc. — Product Code QXD

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: January 19, 2024
Date Received: February 1, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Spinal Imaging System For Neuraxial Procedures
Device Class: Class II
Regulation Number: 868.1985
Review Panel: AN
Submission Type

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.