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

30 October 2026

In plain English

FDA classifies the spinal imaging system for neuraxial procedures as a class II medical device, subject to special controls identified in the order.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
30 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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
The full text is at the source

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