# K031637: Innova 3100 - Pathway: 510(k) (Traditional) - Applicant: GE Medical Systems - Decided: Aug 22, 2003 after 87 days - Product code: OWB (Interventional Fluoroscopic X-Ray System) - Device class: 2 - Regulation: 21 CFR 892.1650 - Recalls of this device: 25 (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). 7 ancestors in all. 76 later devices descend from it; 3 cite it directly. 0 of 84 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K023178: Innova 4100, Ge Medical Systems, Inc. (2002) Summary page 1. - K022322: Innova and Innova 2000 S, Ge Medical Systems, Inc. (2002) Summary page 1. ## Most influential descendants - 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 - 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 ## 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- - 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. - Dec 22, 2009 · Not classified · Z-0618-2010: 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 - Jul 31, 2009 · Not classified · Z-2241-2009: GE Healthcare has recently became aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE e - Apr 16, 2009 · Not classified · Z-0135-2010: 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 - Oct 9, 2008 · Not classified · Z-1688-2009: GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate - Oct 9, 2008 · Not classified · Z-1689-2009: GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate - Jul 25, 2008 · Not classified · Z-2437-2008: The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down. - Jun 24, 2008 · Not classified · Z-2356-2008: 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 - Jun 17, 2008 · Not classified · Z-1475-2009: GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-arch - May 19, 2008 · Not classified · Z-1522-2008: GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch - May 19, 2008 · Not classified · Z-1521-2008: GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch - Mar 6, 2008 · Not classified · Z-1092-2009: GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, a - Jan 30, 2008 · Not classified · Z-0474-2009: Software error, computer: GE Healthcare has became aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, - Jan 14, 2008 · Not classified · Z-2040-2008: 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 - Mar 26, 2007 · Not classified · Z-0871-2007: Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function - Mar 26, 2007 · Not classified · Z-0870-2007: Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function - Mar 26, 2007 · Not classified · Z-0869-2007: Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function - Mar 26, 2007 · Not classified · Z-1044-2007: Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patien - Mar 26, 2007 · Not classified · Z-1043-2007: Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patien - Feb 5, 2007 · Not classified · Z-0914-2007: Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller that may i - Mar 6, 2006 · Not classified · Z-0897-06: Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient. ## Indications for use The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiography procedures of human anatomy. It is intended fo replace image intensifier fluoroscopic systems in all diagnostic or interventional angiography procedures. This device is not intended for mammography applications. Source page: https://510kreport.com/device/K031637 Methodology: https://510kreport.com/methodology