# K092004: GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Aug 25, 2009 after 54 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K926514 (1993). 82 ancestors in all.
No later device cites it as a predicate yet.
1 of 83 devices in its family (counting itself) has 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.
- K060259: Digital Fluoroscopic Imaging Systems - Innova  3131 & Innova 2121, Ge Medical Systems, LLC (2006) Summary page 1.
- K061163: Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ with Innova Ivus Opt, Ge Medical Systems, LLC (2006) Summary page 1.
- K083745: The IC-Pro System, Model Version 3.2, Paieon, Inc. (2009) Summary page 1.
- K031836: Philips Fresco Release 1, Philips Medical Systems North America Co. (2003) Summary page 1.

## Recalls of this device
- Aug 24, 2011 · Not classified · Z-0133-2012: A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails.
- Feb 4, 2011 · Class II · Z-0934-2013: Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.

## Indications for use
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging 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/K092004
Methodology: https://510kreport.com/methodology