# Federal Register #2026-22181

FDA Class II classification and special controls for spinal imaging systems used in neuraxial procedures

**Buyer:** Department of Health and Human Services / Food and Drug Administration
**Posted:** October 30, 2026
**Identifier:** 2026-22181

The FDA issued a final classification order for spinal imaging systems used in neuraxial procedures, establishing them as Class II medical devices subject to special controls.
- Government authority: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), including the Center for Devices and Radiological Health (CDRH).
- **OEM named:** IntuiTap Medical, Inc., which requested De Novo classification for its VerTouch Spinal Imaging Device.
- Device type: A sensor and software system intended to assist in identifying the interspinous space during neuraxial procedures.
- Requirements: Special controls address clinical and non-clinical performance testing, human factors, software verification and validation, electrical, mechanical, thermal, and electromagnetic safety, biocompatibility, sterility, and labeling.
- The device type remains subject to FDA premarket notification requirements.
- This is a regulatory classification action, not a solicitation for products or services; no quantities, part numbers, or contract period are specified.

### Description

The FDA classifies the spinal imaging system for neuraxial procedures as a class II medical device subject to special controls. The device is identified as a sensor and software system used to assist in identifying the interspinous space for neuraxial procedures. The order establishes special controls addressing clinical and non-clinical performance, human factors, software, safety and compatibility, biocompatibility, sterility, and labeling. The classification was applicable January 19, 2024, and the final order is effective October 30, 2026.

[View original listing](https://www.federalregister.gov/documents/2026/10/30/2026-22181/medical-devices-anesthesiology-devices-classification-of-the-spinal-imaging-system-for-neuraxial)