Others titles
- X-Ray Assembler Components
- X-Ray Components
- Medical Device
- FDA X-Ray
- X-Ray Devices
Keywords
- X-Ray Assembler
- X-Ray Components
X-Ray Assembler Components
X-Ray Assembler Components dataset contains the releasable information submitted on form Food and Drug Administration (FDA) 2579 Block 4(h) – under Component Information.
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Description
X-Ray Assembler Components dataset contains information about Components for each X-Ray Assembler Equipment.
Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly (Form FDA 2579) to FDA within 15 days following the completion of the assembly. The report constitutes the assembler’s certification that the components installed are of the type called for by regulations, and that the components were assembled, installed, adjusted, and tested in accordance with the manufacturer’s instructions and meet all applicable performance requirements.
About this Dataset
Data Info
Date Created | 2015-02 |
---|---|
Last Modified | 2021-07-28 |
Version | 2021-07-25 |
Update Frequency |
Quarterly |
Temporal Coverage |
1987 to 2020 |
Spatial Coverage |
United States |
Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | X-Ray Assembler, X-Ray Components |
Other Titles | X-Ray Assembler Components, X-Ray Components, Medical Device, FDA X-Ray, X-Ray Devices |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
ID | ID of X-Ray Assembler Equipment | string | required : 1unique : 1 |
XRay_Control | XRAY CONTROL device | integer | level : Ratiorequired : 1 |
High_Voltage_Generator | HIGH VOLTAGE GENERATOR device | integer | level : Ratiorequired : 1 |
Vertical_Cassette_Holder | VERTICAL CASSETTE HOLDER device | integer | level : Ratiorequired : 1 |
Tube_Housing_Assembly | TUBE HOUSING ASSEMBLY device | integer | level : Ratiorequired : 1 |
Dental_Tube_Head | DENTAL TUBE HEAD device | integer | level : Ratiorequired : 1 |
Cradle | CRADLE device | integer | level : Ratiorequired : 1 |
Film_Changer | FILM CHANGER device | integer | level : Ratiorequired : 1 |
Image_Intensifier | IMAGE INTENSIFIER device | integer | level : Ratiorequired : 1 |
Spot_Film_Device | SPOT FILM DEVICE | integer | level : Ratiorequired : 1 |
Fluoroscopic_Imaging_Assembly | FLUOROSCOPIC IMAGING ASSEMBLY device | integer | level : Ratiorequired : 1 |
Cephalometric_Device | CEPHALOMETRIC DEVICE | integer | level : Ratiorequired : 1 |
Image_Receptor | IMAGE RECEPTOR device | integer | level : Ratiorequired : 1 |
Image_Receptor_Support_Device | IMAGE RECEPTO RSUPPORT DEVICE | integer | level : Ratiorequired : 1 |
Fluoroscopic_Air_Kerma_Device | FLUOROSCOPIC AIR KERMA DEVICE | integer | level : Ratio |
Other | OTHER EQUIPMENT | integer | level : Ratio |
Other_Text | Other text | string | - |
Data Preview
ID | XRay Control | High Voltage Generator | Vertical Cassette Holder | Tube Housing Assembly | Dental Tube Head | Cradle | Film Changer | Image Intensifier | Spot Film Device | Fluoroscopic Imaging Assembly | Cephalometric Device | Image Receptor | Image Receptor Support Device | Fluoroscopic Air Kerma Device | Other | Other Text |
21 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
41 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
61 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
101 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
121 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
141 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
161 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
181 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | |
201 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | |
221 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |