# K091658: GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100, 2100, 3131, 2121

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jun 29, 2009 after 20 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K890348 (1989). 18 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 30 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.
- 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.

## Most influential descendants
- K092439: Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF (2009), 10 descendants of its own
- K093688: Canon, Model Urs-50RF (2010), 5 descendants of its own
- K171194: AS-10, Cxdi-401RF (2017), 3 descendants of its own
- K102529: D2RF Digital Dynamic Remote System (2010), 3 descendants of its own
- K232298: DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl (2024), 1 descendant 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

## 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/K091658
Methodology: https://510kreport.com/methodology