Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
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- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- EAJApron, Leaded1Product Code
- EAKScreen, Leaded, Operator Radiation Protector1Product Code
- IWOApron, Protective1Product Code
- IWPRadiographic Protective Glove1Product Code
- IWQCurtain, Protective, Radiographic1Product Code
- IWRHolder, Syringe, Lead1Product Code
- IWSShield, Eye, Radiological1Product Code
- IWTShield, Gonadal1Product Code
- IWWShield, Vial1Product Code
- IWXBarrier, Control Panel, X-Ray, Movable1Product Code
- KPYShield, Protective, Personnel1Product Code
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Shield, Eye, Radiological
- Page Type
- Product Code
- Regulation Medical Specialty
- Radiology
- Review Panel
- Radiology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 892.6500
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 892.6500 Personnel protective shield
§ 892.6500 Personnel protective shield.
(a) Identification. A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 65 FR 2323, Jan. 14, 2000]