---
kind: "section"
citation: "21 C.F.R. § 868.1980"
title: "21"
number: "868.1980"
heading: "Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia."
url: "https://uscodex.org/cfr/21/868.1980"
---

# §868.1980. Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia.

- (a) **Identification.** This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing under anticipated conditions of use must evaluate the location accuracy of anatomical landmarks identified by the device.
  - (2) Human factors testing must demonstrate that the user can correctly use the device to identify anatomical structures, based solely on reading the instructions for use.
  - (3) Software verification, validation, and hazard analysis must be performed, including demonstrated compatibility with ultrasound devices labeled to be compatible with the device.
  - (4) Labeling must include:
    - (i) The recommended training for safe use of the device;
    - (ii) Pertinent details of the clinical data collected to evaluate the performance of the device; and
    - (iii) **A warning against over-reliance on device output.**

## Notes

### Amendments

[91 FR 32340, June 1, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

### Amendments

[91 FR 32340, June 1, 2026]