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510(k) Data Aggregation
K Number
K161920Device Name
Comfort Cover
Manufacturer
PRECISION DYNAMICS CORPORATION
Date Cleared
2016-07-15
(2 days)
Product Code
IZH, BEE, PRE
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
PRECISION DYNAMICS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of the product is to remove the cold from the bucky by placing this sheet between patient's breast and the image receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.
Device Description
Comfort Cover is a single-use disposable cover placed between the patient's breast and the image receptor plate during mammography. The purpose of this product is to allow the patient to feel more comfortable and less cold during the mammographic examination without interfering with image quality. Comfort Cover will allow for artifact-free images in both Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT), patient radiation dose is equivalent to that when using no Comfort Cover and the Image quality is equivalent to images exposed without Comfort Cover.
Comfort Cover is designed to fit small and large image receptor plates of all leading mammographic equipments. The product is constructed of a fabric material with a purple printed design and has adhesive backing with a paper liner. Both the material and adhesive backing of the product do not affect imaging.
The product is directly applied wrinkle free to the image receptor plate of the mammographic machine by the adhesive backing exposed by peeling off the liner. After the patient's mammogram, the product is peeled off the image receptor plate and disposed. As the product removes cleanly without leaving behind any residue, the image receptor plate does not need to be cleaned between Comfort Covers nor between patients.
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