# K944967: Tomo-Link

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Dec 9, 1994 after 59 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 1 cites it directly.
0 of 31 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
- K051967: Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis (2005), 29 descendants of its own
- K132261: Discovery XR656 with Volumerad (Digital Tomosynthesis) (2013), 21 descendants of its own
- K183275: DR 800 with Tomosynthesis (2019), 8 descendants of its own
- K143270: Optima XR646 (2015), 6 descendants of its own
- K121499: Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System (2012), 6 descendants of its own

Source page: https://510kreport.com/device/K944967
Methodology: https://510kreport.com/methodology