# K033244: Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Oct 16, 2003 after 9 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890348 (1989). 6 ancestors in all.
75 later devices descend from it; 3 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021021: Modular Angiography System Axiom Artis, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- 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

## Recalls of this device
- Dec 11, 2013 · Class II · Z-1163-2014: GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in
- Jan 21, 2013 · Class II · Z-0947-2013: A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-
- Oct 21, 2011 · Class II · Z-1142-2013: As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 a
- May 16, 2011 · Class II · Z-1616-2013: GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.
- Jun 3, 2010 · Not classified · Z-1922-2010: GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.
- Jun 3, 2010 · Not classified · Z-1923-2010: GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.
- Jun 3, 2010 · Not classified · Z-1921-2010: GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.
- Apr 16, 2009 · Not classified · Z-0137-2010: 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

## Indications for use
The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. This device is not intended for mammography applications. The new tilt table will support performing procedures like CO, studies, Venography.

Source page: https://510kreport.com/device/K033244
Methodology: https://510kreport.com/methodology