# K941191: Real Time Stereotix

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: May 11, 1995 after 423 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040125: Senographic Stereo (2004), 18 descendants of its own
- 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

## Recalls of this device
- Jul 1, 2008 · Not classified · Z-2147-2008: GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use 
- Jul 1, 2008 · Not classified · Z-2146-2008: GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use 

Source page: https://510kreport.com/device/K941191
Methodology: https://510kreport.com/methodology