# K202822: Helianthus

- Pathway: 510(k) (Traditional)
- Applicant: Metaltronica Spa
- Decided: Dec 15, 2021 after 447 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P030010 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163328: Planmed Clarity, Planmed OY (2017) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K202822
Methodology: https://510kreport.com/methodology