# K060259: Digital Fluoroscopic Imaging Systems - Innova  3131 & Innova 2121

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Feb 22, 2006 after 21 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K890348 (1989). 16 ancestors in all.
47 later devices descend from it; 4 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ, GE Healthcare (2005) Summary page 1.
- K050489: Innova 2100, Ge Medical Systems, LLC (2005) Summary page 1.
- K974367: Advantx LCN, Advantx LCLP, GE Medical Systems (1998) Summary page 1.
- K033244: Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table Option, Ge Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K081582: Infx-8000V, Infinix-Cfi and Infinix Vfi (2008), 23 descendants of its own
- K061163: Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ with Innova Ivus Opt (2006), 22 descendants of its own
- K101868: Infinix-I Interventional Angiography System Model Infx-8000V (2010), 21 descendants of its own
- K120073: Infx-8000V with (2012), 20 descendants of its own
- K091658: GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100, 2100, 3131, 2121 (2009), 11 descendants of its own

## Recalls of this device
- Aug 16, 2012 · Class II · Z-2376-2012: GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Inn
- Oct 14, 2009 · Not classified · Z-0540-2010: GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to c
- Apr 16, 2009 · Not classified · Z-0138-2010: Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be info
- Nov 21, 2008 · Not classified · Z-1195-2009: GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on

## Indications for use
The Innova 3131 (3131-1Q) and 2121 (2121-1Q) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

Source page: https://510kreport.com/device/K060259
Methodology: https://510kreport.com/methodology