Last synced on 12 July 2024 at 11:04 pm

Cream For X-Ray Attenuation

Page Type
Product Code
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.
Physical State
X-ray attenuating cream
Technical Method
The device consists of a non-toxic, non-heavy metal, radiation absorbing material in a formulated base. Radiation is blocked by the device via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation absorbing material.
Target Area
Healthcare Professional's hands
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.6510
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

No Linked CFR Text

Product code PDK is linked to regulation 21CFR892.6510, which does not seem to exist yet. It may be pending at the moment.

Cream For X-Ray Attenuation

Page Type
Product Code
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.
Physical State
X-ray attenuating cream
Technical Method
The device consists of a non-toxic, non-heavy metal, radiation absorbing material in a formulated base. Radiation is blocked by the device via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation absorbing material.
Target Area
Healthcare Professional's hands
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.6510
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

No Linked CFR Text

Product code PDK is linked to regulation 21CFR892.6510, which does not seem to exist yet. It may be pending at the moment.