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510(k) Data Aggregation
K Number
K073262Device Name
BELLA
Manufacturer
BEEKLEY CORP.
Date Cleared
2008-03-26
(127 days)
Product Code
IZH
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
BEEKLEY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.
Indications for Use: To be applied to the mammography receptor plate, one per patient
Device Description
Bella is to be used on the bucky or the imaging receptor plate of mammography imaging equipment where the breast is placed for mammograms. The purpose of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.
Bella is designed to include a non-woven fabric type material that will feel like fabric on the skin. The material is non-compressable and the sizes are to include all leading mammography equipment for small and large buckies. Bella includes printed graphics to aid in the mental comforting of the patient. There is adhesive backing to Bella which allows easy application and removal from the bucky. The material and adhesive do not affect imaging.
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K Number
K020624Device Name
BREAST BOLSTER
Manufacturer
BEEKLEY CORP.
Date Cleared
2002-09-12
(198 days)
Product Code
IZH
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
BEEKLEY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients.
Device Description
Not Found
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