---
kind: "section"
citation: "21 C.F.R. § 892.1650"
title: "21"
number: "892.1650"
heading: "Image-intensified fluoroscopic x-ray system."
url: "https://uscodex.org/cfr/21/892.1650"
---

# §892.1650. Image-intensified fluoroscopic x-ray system.

- (a) **Identification.** An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
- (b) **Classification.** Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 892.9](/cfr/21/892.9.md). In addition, when intended as an accessory to the device described in [paragraph (a)](#a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 892.9](/cfr/21/892.9.md).

## Notes

### Amendments

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001; 84 FR 71818, Dec. 30, 2019]

### Authority

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

### Source

Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.

### Amendments

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001; 84 FR 71818, Dec. 30, 2019]