# K945375: Advantx Lca

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jan 30, 1995 after 89 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
102 later devices descend from it; 3 cite it directly.
0 of 103 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
- K022322: Innova and Innova 2000 S (2002), 78 descendants of its own
- K031637: Innova 3100 (2003), 76 descendants of its own
- K050489: Innova 2100 (2005), 75 descendants of its own
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ (2005), 74 descendants of its own
- K060259: Digital Fluoroscopic Imaging Systems - Innova  3131 & Innova 2121 (2006), 47 descendants of its own

## Recalls of this device
- Nov 21, 2016 · Class II · Z-0905-2017: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
- Dec 18, 2015 · Class II · Z-0763-2016: GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
- Aug 16, 2013 · Class II · Z-0021-2014: GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Inn
- Dec 22, 2009 · Not classified · Z-0616-2010: Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potentia
- Jun 24, 2008 · Not classified · Z-2359-2008: GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3
- Jan 14, 2008 · Not classified · Z-2038-2008: Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system

Source page: https://510kreport.com/device/K945375
Methodology: https://510kreport.com/methodology