HELIANTHUS M-HELI

GUDID 08052405210050

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

METALTRONICA SPA

Stationary mammographic x-ray system, digital

• Primary Device ID: 08052405210050
• NIH Device Record Key: 3532c009-9c6e-4931-b052-45f8fa7c7aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELIANTHUS
• Version Model Number: HELIANTHUS
• Catalog Number: M-HELI
• Company DUNS: 428856827
• Company Name: METALTRONICA SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052405210050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202822

FDA Product Code

• MUE: Full Field Digital, System, X-Ray, Mammographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-04-01
• Device Publish Date: 2026-03-24