Shield, Eye, Radiological
A radiological eye shield is a small lead or radiation-attenuating protective device placed over or near the eyes during radiological procedures to reduce radiation dose to the ocular lens, which is particularly sensitive to radiation-induced injury. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWS, regulated under 21 CFR 892.6500, within the Radiology medical specialty.
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Basic Information
- Product Code
- IWS
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945515 | COATED TUNGSTEN EYESHIELD | Jun 19, 1995 | Substantially Equivalent | Medtec, Inc. |
| K940119 | ROYAL MARSDEN GOLD GRAIN GUN | Dec 30, 1994 | Substantially Equivalent | Best Industries |
| K943011 | TUNGSTEN EYESHIELD | Dec 23, 1994 | Substantially Equivalent | Medtec, Inc. |
| K934459 | MED-GENESIS PATIENT LASER EYE SHIELD | Feb 22, 1994 | Substantially Equivalent | Med-Genesis, Inc. |
| K934362 | NUCLEAR ASSOCIATES GLASSERS | Nov 12, 1993 | Substantially Equivalent | Victoreen, Inc. |
| K920540 | RADIOLOGICAL PROTECTIVE EYE SHIELD | May 28, 1992 | Substantially Equivalent | Burkhart Roentgen Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.