# K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ - Pathway: 510(k) (Traditional) - Applicant: GE Healthcare - Decided: Sep 16, 2005 after 14 days - Product code: OWB (Interventional Fluoroscopic X-Ray System) - Device class: 2 - Regulation: 21 CFR 892.1650 - Recalls of this device: 50 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K890348 (1989). 14 ancestors in all. 74 later devices descend from it; 8 cite it directly. 0 of 89 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K974715: Advantage 3D XR, GE Medical Systems (1998) Summary page 1. - K050489: Innova 2100, Ge Medical Systems, LLC (2005) Summary page 1. - K033244: Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table Option, Ge Medical Systems, Inc. (2003) Summary page 1. - K031637: Innova 3100, GE Medical Systems (2003) Summary page 1. ## Most influential descendants - 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 - K120073: Infx-8000V with (2012), 20 descendants of its own ## Recalls of this device - Sep 4, 2014 · Class II · Z-0453-2015: Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism. - Dec 20, 2011 · Class II · Z-1318-2013: While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribu - 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 - 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. - 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. - 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. - Mar 24, 2010 · Not classified · Z-1660-2010: A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data - Mar 24, 2010 · Not classified · Z-1659-2010: A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data - Mar 24, 2010 · Not classified · Z-1661-2010: A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data - 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 - Dec 22, 2009 · Not classified · Z-0617-2010: 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 - Dec 22, 2009 · Not classified · Z-0619-2010: 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 - Aug 5, 2009 · Not classified · Z-0408-2011: GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to mainta - Aug 5, 2009 · Not classified · Z-0410-2011: GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to mainta - Aug 5, 2009 · Not classified · Z-0409-2011: GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to mainta - Apr 16, 2009 · Not classified · Z-0136-2010: 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 - 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 - 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 - Nov 4, 2008 · Not classified · Z-1036-2009: One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thus cumulative Air Kerma are overestimated. The Air K - Oct 9, 2008 · Not classified · Z-1691-2009: 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-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-1687-2009: 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-1690-2009: 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-2438-2008: 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. - Jul 25, 2008 · Not classified · Z-2436-2008: 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. - 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-2357-2008: 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 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 24, 2008 · Not classified · Z-2358-2008: 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 - Jun 17, 2008 · Not classified · Z-1476-2009: 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 - Jun 17, 2008 · Not classified · Z-1474-2009: 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 - Jan 30, 2008 · Not classified · Z-0473-2009: 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 30, 2008 · Not classified · Z-0475-2009: 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 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-2039-2008: 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 - 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 - Jan 14, 2008 · Not classified · Z-2041-2008: 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 - Nov 15, 2007 · Not classified · Z-0692-2008: Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In - Nov 15, 2007 · Not classified · Z-0691-2008: Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In - 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-0913-2007: 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 - Aug 17, 2006 · Not classified · Z-1518-2008: User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any - Aug 17, 2006 · Not classified · Z-1519-2008: User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any - Aug 17, 2006 · Not classified · Z-1520-2008: User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any ## 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 fluoroscoplc images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications. InnovaSpin is a software option that permits fast spin rotational angiography. 1t is not intended for mammography applications. Source page: https://510kreport.com/device/K052412 Methodology: https://510kreport.com/methodology