Description
This guidancewas written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.
Scope & Applicability
Product Classes
2Change allows assemblers to install manual beam-limiting devices in these systems
The guidance focuses on information disclosure for these systems.; The guidance covers information disclosure for these systems.
Stakeholders
2Responsible for declaring acceptable market names on labels.
Entities that assemble convenience kits from legally marketed devices.
Regulatory Context
Attributes
2Diagram labels SID of 110 cm and 90 cm
Measurement of EER in AERC mode
Related CFR Sections (4)
- 21CFR1020.31§ 1020.31 Radiographic equipment.
The provisions of this section apply to equipment for radiography, except equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, or computed tomography x-ray systems manufactured on or after November 29, 1984.Read full regulation →
- 21CFR1020.33§ 1020.33 Computed tomography (CT) equipment.
(a) Applicability.Read full regulation →
- 21CFR1020.32§ 1020.32 Fluoroscopic equipment.
The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.Read full regulation →
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability.Read full regulation →
See Also (8)
- Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 (Status: Final)
- Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (Status: Final)
- Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Guidance for Industry and Food and Drug Administration Staff (Status: Final)