# K012953: Giotto Image

- Pathway: 510(k) (Traditional)
- Applicant: Medx, Inc.
- Decided: Nov 30, 2001 after 87 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901558 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973856: Giotto HT, Sitco, Inc. (1997) Summary page 1.

## Most influential descendants
- K111434: Giotto Image 3D, Giotto Image 3D-L (2011), 0 descendants of its own

## Indications for use
The Giotto Image X-ray Mammographic System is intended to provide film-screen X-ray imaging of the breast that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto Image can also be used as the imaging device for stereotactic needle biopsy.

Source page: https://510kreport.com/device/K012953
Methodology: https://510kreport.com/methodology