Description
Thisguidance documentintends to clarify FDA’s interpretation of certain aspects of the performance standard requirements in 21 CFR 1020.30 and 1020.32 for fluoroscopic equipment.
Scope & Applicability
Product Classes
3classified in 21 CFR 892.1600
Systems requiring LIH and air kerma displays
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
2The user at the working position to whom displays and signals are directed.
Entity responsible for submitting NDINs
Regulatory Context
Attributes
4Total air kerma displayed in units of mGy.
Measurement required to be displayed in fluoroscopy
cumulative duration of operator-applied continuous pressure
used to describe radiation-related quantities in performance standards
Identified Hazards
Hazards
1Hazardous and unnecessary exposure from electronic products
Related CFR Sections (4)
- 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 →
- 21CFR892.1600§ 892.1600 Angiographic x-ray system.
(a) Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supRead full regulation →
- 21CFR892.1650§ 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, patiRead full regulation →
See Also (8)
- Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide (Status: Final)
- Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment (Status: Final)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (Status: Final)
- CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers (Status: Final)