Cream For X-Ray Attenuation
The Cream for X-Ray Attenuation is a radiology device intended for use as a radiation shield, applied to the user's hands by interventional radiology or cardiology personnel to reduce radiation exposure to the hands during fluoroscopic procedures. It falls under the Radiology medical specialty and is classified as a Class 2 device under regulation 892.6510, requiring 510(k) premarket notification. This topical cream provides supplementary radiation protection in addition to conventional lead shielding. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PDK
- Device Class
- FDA class 2
- Regulation Number
- 892.6510
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.
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 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.