# K931049: Advantx System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: May 19, 1993 after 79 days
- Product code: IZO (Generator, High-Voltage, X-Ray, Diagnostic)
- Device class: 1
- Regulation: 21 CFR 892.1700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Mar 9, 2007 · Not classified · Z-0200-2009: GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has been reported that s

Source page: https://510kreport.com/device/K931049
Methodology: https://510kreport.com/methodology