DEN220009 is an FDA 510(k) submission for the VerTouch Spinal Imaging Device. This device is classified as a Spinal Imaging System For Neuraxial Procedures (Class II - Special Controls, product code QXD).
Submitted by Intuitap Medical, Inc. (Houston, US). The FDA issued a Not Cleared (DENG) decision on January 19, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1985. 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..
| 510(k) Number | DEN220009 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 01, 2022 |
| Decision Date | January 19, 2024 |
| Days to Decision | 717 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | QXD - Spinal Imaging System For Neuraxial Procedures |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1985 |
| 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. |