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510(k) Data Aggregation
K Number
K123414Device Name
SPECBOARD JR.
Manufacturer
MACBRUD CORP., MEDICAL DIVISION
Date Cleared
2013-01-11
(66 days)
Product Code
IZH
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
MACBRUD CORP., MEDICAL DIVISION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SPECBOARD JR is intended to be used as an accessory to a mammographic x-ray system. The SPECBOARD JR is used to contain the mammographic specimen from the patient when transported to the x-ray device and then accompany the x-ray image to the pathology laboratory.
Device Description
The SPECBOARD is a medical device that allows for accurate localization of suspect lesions in breast tissue. The SPECBOARD JR is comprised of a foam core base coupled with a tape hinge along one edge to a thick cardboard cover. On the base foam core piece there is a centrally located piece of absorbent blotter paper. Along two joining edges of the blotter are two radio-opaque nickel stencils, one marked with alpha characters and the other with numerical characters. The SPECBOARD JR is used in the operating room where the surgeon will remove a suspect portion of the breast tissue and place it on the blotter portion of the SPECBOARD JR. The cover is then closed, sandwiching the breast specimen between the cover and the base. The cover is then secured with the Velcro latch and an x-ray is taken of the specimen inside the SPECBOARD JR. The resulting x-ray image will show the perpendicular stencils along the border of the blotter paper and the specimen on the blotter paper. Any lesions will show up within the specimen and the pathologist then has a reference of where to cut into the specimen to withdrawal a piece for analysis.
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