Table of Contents
Advertisement
Intended Use
Intended Use
These devices are indicated for digital imaging solutions designed to provide general
radiographic diagnosis for human anatomy including both adult and pediatric patients.
They are intended to replace film/screen systems in all general-purpose diagnostic
procedures. This device is not intended for mammography or dental applications.
Application Specification
Patient Population
•
Adult and pediatric patients
Pediatric Use: Guidance & Considerations
Special care should be exercised when imaging patients outside the typical adult size
range, especially smaller pediatric patients whose size does not overlap the adult size
range (for example, less than 50 kg (110 lb) in weight and 150 cm (59 in.) in height,
measurements which approximately correspond to that of an average 12 year old.
The following ranges of pediatric subpopulations are to be used as a guide for
manufacturers in developing medical devices:
Newborn (Neonate)
Infant
Child
Adolescent
Exposure to ionizing radiation is of particular concern in pediatric patients because:
1. For certain organs and tumor types, younger patients are more radio sensitive than
adults (the cancer risk per unit dose of ionizing radiation is higher for younger
patients);
2. Use of equipment and exposure settings designed for adults of average size can
result in excessive and unnecessary radiation exposure of smaller patients;
3. Younger patients have a longer expected lifetime putting them at higher risk of
cancer from the effects of radiation exposure.
To help reduce the risk of excessive radiation exposure, you should follow the ALARA
(As Low As Reasonably Achievable) principle and seek to reduce radiation dose to only
the amount necessary to obtain images that are adequate clinically.
AL4608
Pediatric Subgroup
Approximate Age Range
From birth to 1 month of age
Greater than 1 month to 2 years of age
Greater than 2 to 12 years of age
Greater than 12 through 21 years of age
1-11
Safety and Regulatory Information
2021-09-07
Advertisement
Table of Contents
