# K945459: DLX

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Jan 30, 1995 after 84 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
333 later devices descend from it; 2 cite it directly.
10 of 334 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
- K993037: LCV+ Version 2 (2000), 330 descendants of its own
- K021021: Modular Angiography System Axiom Artis (2002), 218 descendants of its own
- K020055: Philips Integris Allura 9 with FD Option (2002), 124 descendants of its own
- K022899: Philips Integris Allura Flat Detector Release 1.0 (2002), 114 descendants of its own
- K031333: Philips Integris Allura Flat Detector Release 1.2 (2003), 113 descendants of its own

Source page: https://510kreport.com/device/K945459
Methodology: https://510kreport.com/methodology