On October 30, 2026, the Food and Drug Administration (FDA) issued a final order classifying the spinal imaging system for neuraxial procedures into class II (special controls). The FDA determined that this classification will provide a reasonable assurance of the safety and effectiveness of the device. The full text of the order is available in the Federal Register document.

Press Release: Food and Drug Administration

Published October 30, 2026. Reproduced in full from the Food and Drug Administration.

Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures

Action: Final amendment; final order.

Summary

The Food and Drug Administration (FDA) is classifying the spinal imaging system for neuraxial procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the spinal imaging system for neuraxial procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Key dates

  • Takes effect: October 30, 2026

This order is effective October 30, 2026. The classification was applicable on January 19, 2024.

Full text: Federal Register document 2026-22181