CFR section
21 CFR 1020.33(c)(3): Computed tomography (CT) equipment
PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
Key facts
| Citation | 21 CFR 1020.33(c)(3) |
|---|---|
| Section | Computed tomography (CT) equipment |
| Part | PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (3) Imaging performance information. The following performance data shall be provided for the CT conditions of operation used to provide the information required by paragraph (c)(2)(i) of this section. All other aspects of data collection, including the x-ray attenuation properties of the material in the tomographic section, shall be similar to those used to provide the dose information required by paragraph (c)(2)(i) of this section. For any CT x-ray system designed to image both the head and… |
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