# K111434: Giotto Image 3D, Giotto Image 3D-L

- Pathway: 510(k) (Traditional)
- Applicant: Giotto USA, LLC
- Decided: Oct 27, 2011 after 157 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 K901558 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P990066: GE Healthcare Senographe Full Field Digital Mammography System, GE Healthcare (2000) Summary page 1.
- K012953: Giotto Image, Medx, Inc. (2001)

## Indications for use
The intended use of the Giotto Image 3D is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer. The intended use of the Giotto Image 3D-L 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/K111434
Methodology: https://510kreport.com/methodology