# K040125: Senographic Stereo

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Apr 19, 2004 after 90 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: 1 generation back to K941191 (1995). 1 ancestor in all.
18 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941191: Real Time Stereotix, GE Medical Systems (1995) Summary page 1.

## Most influential descendants
- K071542: Digital Stereoloc II (2007), 14 descendants of its own
- K103512: Affirm Breast Biopsy Guidance System (2011), 13 descendants of its own
- K122836: Affirm Breast Biopsy Guidance System (2013), 9 descendants of its own
- K173408: Mammomat Revelation (2018), 6 descendants of its own
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own

## Indications for use
Senographe Stereo is an optional accessory for the Senographe DS full field digital system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from steroetactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).

Source page: https://510kreport.com/device/K040125
Methodology: https://510kreport.com/methodology