---
kind: "section"
citation: "21 C.F.R. § 892.1940"
title: "21"
number: "892.1940"
heading: "Radiologic quality assurance instrument."
url: "https://uscodex.org/cfr/21/892.1940"
---

# §892.1940. Radiologic quality assurance instrument.

- (a) **Identification.** A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
- (b) **Classification.** Class I (general controls). The 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). The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001; 90 FR 55995, Dec. 4, 2025]

### 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 38819, July 25, 2001; 90 FR 55995, Dec. 4, 2025]