# K243420: Hestia

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Jul 17, 2025 after 255 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: 6 generations back to P030010 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212873: Aspire Cristalle, Fujifilm Corporation (2022) Summary page 5.

## Indications for use
HESTIA is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. HESTIA is intended to be used in the same clinical applications as traditional film/screen systems.

Source page: https://510kreport.com/device/K243420
Methodology: https://510kreport.com/methodology