# K200424: Giotto Class (Models - 3000X-YY and 4000X-YY)

- Pathway: 510(k) (Special)
- Applicant: Ims Giotto S.P.A.
- Decided: Jun 18, 2020 after 119 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of the device Giotto Class is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

Source page: https://510kreport.com/device/K200424
Methodology: https://510kreport.com/methodology