Shield, Gonadal
A gonadal shield is a lead-lined or radiation-attenuating protective device placed over the reproductive organs of patients during radiological procedures to reduce radiation dose to the gonads, particularly important in pediatric and reproductive-age patients. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWT, regulated under 21 CFR 892.6500, within the Radiology medical specialty.
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Basic Information
- Product Code
- IWT
- Device Class
- FDA class 1
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.