Helianthus
Metaltronica Spa
Metaltronica Spa
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009868110 | 3009868110 | Metaltronica Spa | 1 | N | 2026-01-01 | Pomezia (RM) via delle Monachelle 66 Pomezia Roma IT 00071 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 320575 | 1065481104 | K202822 | Helianthus | MUE | 2021-12-15 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MUE | 1 | 2021-12-15 |
PMN#
GUDID#
SERENYS DR - SERENYS DR is a mammography solution composed of equipment and software for different examination types and optimized for digital imaging. SERENYS DR 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.
2026-05-25
HELIANTHUS - 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
2026-03-24