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510(k) Data Aggregation
K Number
K110900Device Name
DISPOSABLE THYROID COLLAR
Manufacturer
BLOXR CORPORATION
Date Cleared
2011-06-24
(85 days)
Product Code
KPY
Regulation Number
892.6500Why did this record match?
Product Code :
KPY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Thyroid Collar is intended for use as a radiation shield against scatter radiation. It is intended to be placed around the neck of the user who remains outside of the primary radiation beam.
Device Description
The Disposable Thyroid Collar is a radiation protective shield for the thyroid intended to be used in various medical procedures where X-ray radiation is used. It is a non-sterile device, designed for single use. The device is constructed with environmentally friendly radiation attenuating materials, which do not contain lead or heavy metals. The radiation attenuating material is encased in a medical grade polypropylene (PP) non-woven drape material. The device is available in three sizes, small, medium, and large.
The device blocks radiation in a similar manner to lead - 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 attenuating material, in a manner identical to lead.
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K Number
K962622Device Name
INTRA-ORAL THERMOPLASTIC SHIELD
Manufacturer
MEDTEC, INC.
Date Cleared
1996-10-01
(88 days)
Product Code
KPY
Regulation Number
892.6500Why did this record match?
Product Code :
KPY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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