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510(k) Data Aggregation
K Number
K202822Device Name
Helianthus
Manufacturer
Metaltronica Spa
Date Cleared
2021-12-15
(447 days)
Product Code
MUE
Regulation Number
892.1715Why did this record match?
Applicant Name (Manufacturer) :
Metaltronica Spa
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Helianthus is intended to produce two dimensional digital mammographic images of the breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy.
Device Description
Helianthus is a mammography solution composed of equipment and software for different examination types and optimized for digital imaging.
Helianthus is a digital mammography system also called full-field digital mammography (FFDM) system. It is an integrated system that includes both the X-ray delivery system and integrated detector. It consists of an x-ray generator, x-ray control, x-ray tube, collimator, beam filter, breast compression system, grid, image receptor system, and accessories. The image receptor system consists of a built-in full-filed solid state detector, acquisition software, acquisition work station (AWS), and accessories. It includes an optional stereotactic biopsy device (BYM 3D DMD) with its respective Operator's Manual.
Helianthus is intended to produce two-dimensional digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy
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